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Williams, Roger L. "Official USP Reference Standards: Metrology concepts, overview, and scientific issues and opportunities." Journal of Pharmaceutical and Biomedical Analysis 40, no. 1 (January 2006): 3–15. http://dx.doi.org/10.1016/j.jpba.2005.07.017.
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Caskey, Tina, Carolyn Montei, Daniel Krause, Susan McDougal, Melanie Graham, Preetha Biswas, and Robert Donofrio. "Rapid Automated System for the Detection of Objectionable Microorganisms in Nutraceutical and Dietary Supplements." Journal of AOAC INTERNATIONAL 103, no. 1 (January 1, 2020): 272–77. http://dx.doi.org/10.5740/jaoacint.19-0082.
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Abstract Background: The U.S. Pharmacopeia (USP) established microbiological procedures to evaluate nonsterile products and nutritional and dietary supplements for objectionable microorganisms of concern in the industry. A rapid method has been developed to detect the presence of microorganisms based on real-time photometric monitoring of pH, carbon dioxide, or fluorescence indicators within a novel broth/agar combination vial and accompanying reader. Objective: To validate the performance of the Neogen Rapid Microbiology System (NRMS) method against the USP reference method for the ability to detect presence or the absence of Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa in nutraceutical and dietary supplements. Methods: Over 200 samples were evaluated for the presence of objectionable microorganisms. For each specified microorganism, a minimum of 23 matrices were tested uninoculated and with a low-level inoculum of <1–27.4 CFU/g, as paired samples, by NRMS and USP methods. Results: In the four objectionable microorganism categories evaluated, 100% inclusivity, 97–100% exclusivity, 97–100% positive predictivity, 100% negative predictivity, and Kappa Indices of 0.97–1.0 were achieved following ISO 5725-6:1994 standards. Conclusions: The validation study demonstrates that NRMS is a rapid and effective method to detect objectionable microorganisms in a variety of nutraceutical and dietary supplements. Highlights: A novel method was validated against the relevant USP reference method for the detection of Escherichia coli, Salmonella, Staphylococcus aureus, and Pseudomonas aeruginosa in nutraceutical and dietary supplements. NRMS provided results statistically comparable to the USP reference method within 22 h following primary enrichment compared with 5–7 days by the reference method.
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Mattiazzi, Patricia, Denise Bohrer, Carine Viana, and Emilene Becker. "Assessment of Purity Parameters of Generic and Brand Name Losartan Potassium." Current Pharmaceutical Analysis 17, no. 1 (November 23, 2020): 129–39. http://dx.doi.org/10.2174/1573412915666190911091218.
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Background: Generic products must be bioequivalent to the innovator brand product. Nevertheless, in addition to meeting bioequivalence standards, attention must be paid to the content of the active substance and contaminants in generic drugs. Objective: This study compared the pharmaceutical quality of four generic losartan potassium formulations with the brand-name product: Cozaar®. Methods: The United States Pharmacopeia (USP) losartan potassium standard was used as reference material. The products tested (all 50 mg formulations) included four generic tablet formulations and the innovator brand product Cozaar®. Active substance content, organic impurities, and elemental impurities were assessed following the USP monograph for losartan potassium tablets and USP Chapter <233> on Elemental Impurities. Results: The results showed that three of the four generic products had low content of the active ingredient. The values ranged from 86.4 to 93.8%, being acceptable not below 95% of the labeled amount. Organic impurities were not detected in any of the products, and of the 13 elemental impurities tested, only four elements were detected. The elemental impurities Cr, Ni, Cu, and As were, however, in amounts within the limits established by the USP monograph. The only concern on the generic drugs analyzed was the low content of the active ingredient in 75% of the products. Conclusion: Since losartan is a drug of continuous use, lower content of the active ingredient may go unnoticed by the users of the generic product and entailed clinical consequences during long-term therapy.
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Jeske, Walter P., Josephine Cunanan, Debra Hoppensteadt, Jeanine M. Walenga, Omer Iqbal, Michelle Florian-Kujawski, and Jawed Fareed. "Discordance between the 1st and 2nd Low Molecular Weight Heparin Standards. Implications for Dosing." Blood 106, no. 11 (November 16, 2005): 4158. http://dx.doi.org/10.1182/blood.v106.11.4158.4158.
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Abstract Soon after the introduction of low molecular weight heparins (LMWHs) as antithrombotic agents, a LMWH standard to cross-reference the potency of commercially available LMWHs was developed. For the past 15 years, this standard has been used by manufacturers to cross-reference their branded LMWHs. The 1st LMWH standard (85/600) was produced by nitrous acid digestion of porcine mucosal heparin. This standard had characteristics that were comparable to dalteparin. Because of the widespread use of the first standard, the supplies are now depleted necessitating the introduction of new standard material. The WHO has introduced a 2nd LMWH standard which is also produced by nitrous acid digestion and which mimics the commercially available LMWH reviparin. The molecular weight profile and the biologic activities, including SERPIN affinity, of these two standards are very distinct. When used to cross-reference commercially available LMWHs such as enoxaparin, the new standard consistently overestimates the anti-Xa potency by 5–10% in comparison to the first standard. Such an overestimation may lead to a reduction in dosage and have a significant impact on the clinical dosing of LMWH in various indications. As many generic versions of LMWHs are currently being introduced, a systematic study was carried out to cross-reference three commercially available generic products from India and South America against the first and second LMWH standards using amidolytic anti-Xa and anti-IIa assays. Differences were observed in the slopes of the concentration-response curves for these standards in both the anti-Xa and anti-IIa assays. The potencies of the generic LMWHs ranged from 141 to 152 U/mg in relation to the first standard and from 132 to 143 U/mg in relation to the second standard. On average, the anti-Xa potency was 6.5% lower when calculated with the 2nd standard. The differences in anti-IIa potency were further amplified and exhibited wider variation. On average, the anti-IIa potency was 18.9% lower when calculated with the 2nd standard. These studies clearly demonstrate that the limitations in the use of the first and second LMWH standards for cross-referencing commercially available LMWHs and their potential generic versions. If the 2nd standard is used, it should first be cross-referenced against the first standard in order to properly assign the anti-Xa and anti-IIa activities. This study also underscores the need for developing individual standards for each of the branded products. Such standards should be defined in terms of not only anti-Xa and anti-IIa activity, but also in terms of anticoagulant activity in global clotting assays such as the USP assay, activated clotting time (ACT), aPTT and Heptest. Such designations will be particularly useful in evaluating the potential equivalence of generic versions of branded LMWHs.
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Kenyon, Allen S., Paul E. Flinn, and Thomas P. Layloff. "Rapid Screening of Pharmaceuticals by Thin-Layer Chromatography: Analysis of Essential Drugs by Visual Methods." Journal of AOAC INTERNATIONAL 78, no. 1 (January 1, 1995): 41–49. http://dx.doi.org/10.1093/jaoac/78.1.41.
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Abstract A method for rapidly screening pharmaceuticals by thin-layer chromatography has been designed for use in areas with limited resources and by operators with limited training. An apparatus for performing the analysis in a plastic bag under equilibrium conditions was designed. Results can be reproduced by different operators and in different locations. The analysis can be performed without electricity or in a remote area, away from a laboratory. It is especially suited for field use in developing countries. The method is low cost, maintenance-free, fast, and reliable; it also uses limited volumes of solvents. The analyses can be performed without weighing if reference materials can be supplied in tablet form, provided the drug content is listed and only one unit is required for each analysis. All procedures were developed for the analysis of drugs from a partial list of essential drugs established by the World Health Organization. Three drugs were selected and prepared in the form of reference tablets. Comparisons with the analyses of the drugs in standard dosage forms were made by using reference tablets and primary USP standards. Comparable results were obtained, proving that the screening process can be conducted by using reference tablets and without weighing either the sample or the reference. The method has been successfully demonstrated and used in Swaziland, by high school teachers in the United States, and by personnel from the Ministry of Health in Saudi Arabia. Personnel can be trained in a short time to perform screening analysis of drugs.
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Nogueira, Luciana, Fernanda Raffin, and Alejandro Ayala. "The relevance of polymorphism in rifampicin." Acta Crystallographica Section A Foundations and Advances 70, a1 (August 5, 2014): C637. http://dx.doi.org/10.1107/s2053273314093620.
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Tuberculosisis is an infectious Neglected Tropical Disease (NTD) considered a public health problem in several countries. Rifampin (RIF) is one of the first choice drugs in the treatment of this disease since it has bactericidal action on susceptible strains of Mycobacterium tuberculosis, the etiological agent of tuberculosis affecting humans. According to the literature RIF can exist in two polymorphic forms, namely forms I and II, a penta-hydrate and an amorphous solid1. Each form has different solubility in aqueous medium affecting the bioavailability of the drug when it formulated in solid dosage forms for oral administration since they are expected to content form II2. The objective of this research is to characterize and understand in detail the pharmaceutically relevant forms of RIF. It is an important and challenging problem related to the development of formulations because the physical mixture of these forms is usually observed in raw materials from generic suppliers. Thus, the reference sample (USP standard) and two lots from different suppliers were investigated by electron microscopy, Raman and infrared spectroscopies, X-ray diffraction powder and thermal analysis. In addition, pure samples of these solid forms were produced by recrystallization under different conditions in order to establish the structural reference standards. The results of this study will be useful for the development of efficient quality control methods for a drug which is very important to the social health programs.
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Andrews, Karen, Pavel Gusev, Sushma Savarala, Phuong-Tan Tey, Laura Oh, Ronelle Bautista, Renata Atkinson, et al. "Comparison of Label Claims, Measured Curcuminoid Content and Dosage Form Performance Quality With Industry Standards for Turmeric Dietary Supplements." Current Developments in Nutrition 5, Supplement_2 (June 2021): 296. http://dx.doi.org/10.1093/cdn/nzab037_006.
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Abstract Objectives Turmeric (Curcuma longa) is a popular ingredient in dietary supplements (DS), promoted for a variety of health effects. FDA label regulations require information on the total weight of each botanical or extract present in a botanical DS, unless it is part of a proprietary blend. Information on the concentration of phytochemicals in extracts is voluntary. DS with turmeric rhizome powders and/or extracts were tested for curcuminoid content and the results compared to label claims and industry standards as part of the Dietary Supplement Ingredient Database (DSID) research program. The performance quality of the dosage forms was also evaluated. Methods Commonly consumed DS (n = 54 × 2 lots) with turmeric as the only or primary ingredient were analyzed for curcumin, demethoxycurcumin, and bisdemethoxycurcumin. Certified reference materials, in-house controls and blind sample duplicates were measured to ensure the quality of results from three laboratories. Percentages of total curcuminoids (TC) and ratios of the three curcuminoids were compared to published standards. Voluntary content claims were categorized as “complete” (all listed turmeric ingredients had a TC claim) or “partial” (only one of two had a TC claim). Tablets/caplets (n = 9) and capsules (n = 39) were also tested for disintegration and soft gels (n = 4) for rupture. Results Measured TC amounts varied widely among products. At the most common labeled level of 500 mg of turmeric per day, measured TC results ranged from 16 to 554 mg (n = 12). DS with voluntary claims for TC (n = 41) had analytical content averaging 6.2% above label, and 63% within ± 10% of claims. DS with complete TC claims had significantly higher levels in mg per day than those with partial or no claims (735 ± 87, 137 ± 37, 196 ± 57; mean ± SE, respectively). The curcuminoid ratios and/or the percentages of TC differed significantly from United States Pharmacopeial (USP) standards for at least 10 DS. Most (87.5%) DS passed disintegration tests and all soft gels passed the rupture test. Conclusions Current labeling requirements for turmeric DS may be insufficient to inform researchers and consumers about the actual content of TC in DS because the extract concentrations vary widely. Voluntary claims for TC amounts were reasonably accurate. Most turmeric DS met USP disintegration and composition standards. Funding Sources NIH-ODS and USDA-ARS.
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Basha, N. S., R. Rekha, A. Letensie, and S. Mensura. "Preliminary Investigation on Sodium Alginate Extracted from Sargassum Subrepandum of Red Sea of Eritrea as Tablet Binder." Journal of Scientific Research 3, no. 3 (August 29, 2011): 609–18. http://dx.doi.org/10.3329/jsr.v3i3.6770.
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Natural polysaccharides hold advantages over synthetic polymers for conventional and novel dosage forms, because these are non-toxic, less expensive, and biodegradable. These can also be modified to tailor-made materials and thus can compete with the available synthetic excipients. Therefore, the aim of present work is to extract sodium alginate from the seaweed S. subrepandum to assess its binding property using propranolol as model drug. Sodium alginate was extracted by room-temperature alkaline extraction and high-temperature (80°C) alkaline extraction methods. Binding strength was evaluated by using two different formulations i.e., formulation 1 with sodium alginate as a binder and formulation 2 with hydroxypropylmethylcellulose (HPMC) as reference standard. The two tablet formulations were evaluated and compared for parameters such as friability, hardness and disintegration. The percentage yield was found to be 17.5% w/w by room-temperature alkaline extraction and 21%w/w by high-temperature extraction method. The results obtained for all tested parameters for tablets with sodium alginate were found within acceptable range of USP standards. It was also founded that both sodium alginate and HPMC have similar binding strength at similar concentration. So, it can be concluded that sodium alginate of S. subrepandum can be used as suitable alternative binder in tablet formulations.Keywords: Sargassum subrepandum; Sodium alginate; Hydroxypropyl methylcellulose; Friability; Hardness; Disintegration.© 2011 JSR Publications. ISSN: 2070-0237 (Print); 2070-0245 (Online). All rights reserved.doi:10.3329/jsr.v3i3.6770 J. Sci. Res. 3 (3), 619-628 (2011)
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Antonova, N. P., E. P. Shefer, N. E. Semenova, A. M. Kalinin, S. S. Prokhvatilova, and I. M. Morgunov. "Application of HPLC for Evaluation and Standardisation of Hawthorn Flower Herbal Substance." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 9, no. 3 (September 10, 2019): 177–83. http://dx.doi.org/10.30895/1991-2919-2019-9-3-177-183.
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The process of harmonisation of Russian and foreign approaches and requirements in the field of medicines quality assurance calls for revision of quality control procedures included in various regulations and guidelines. The monograph FS.2.5.0062.18 “Hawthorn flowers” of the State Pharmacopoeia of the Russian Federation XIV edition includes a test procedure for determination of flavonoids by a chromatospectrophotometric method. This procedure does not take into account current scientific capabilities and has a number of shortcomings, therefore it was necessary to revise the existing test procedure and develop a new approach to the standardisation of the hawthorn flower herbal substance.The objective of the study was to develop an assay method for standardisation and evaluation of hawthorn flower using high performance liquid chromatography (HPLC).Materials and methods: the study was performed using samples of hawthorn flowers by Russian manufacturers. Quercetin (USP RS) and Hyperoside (HWI, primary standard) were used as the reference standards. The HPLC analysis was performed using an Infinity II 1260 DAD LC system (Agilent), and the UV spectra were recorded on a Cary 100 Varian spectrophotometer. A TLC Visualizer (CAMAG) was used to obtain digital images of thin layer chromatography plates.Results: the authors developed an HPLC test procedure for quantitative determination of total flavonoids, expressed as hyperoside, in hawthorn flowers. The developed procedure gives reliable and reproducible results and is characterised by high sensitivity and selectivity. The results of quantitative determination of the total flavonoid content in hawthorn flowers were used to propose the standard for the total content of flavonoids, expressed as hyperoside, of “not less than 0.5%”.Conclusions: the developed assay method for determination of active pharmaceutical ingredients in hawthorn flower products by HPLC can be recommended for inclusion into the Assay part of the “Hawthorn Flowers” monograph of the State Pharmacopoeia of the Russian Federation.
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Kirchhoefer, Ross D. "Niacin II: Identification of Isonicotinic Acid in Niacin by Liquid Chromatography with Diode Array Detection." Journal of AOAC INTERNATIONAL 77, no. 3 (May 1, 1994): 587–90. http://dx.doi.org/10.1093/jaoac/77.3.587.
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Abstract Isonicotinic acid impurity in bulk niacin was detected and identified by comparison with a reference material by liquid chromatography with a diode array detector. The niacin was dissolved in dilute hydrochloric acid and chromatographed on an amine column with a mobile phase of methanol and water acidified with formic acid. Isonicotinic acid has a relative retention time of 1.5 compared with niacin (nicotinic acid), and the wavelengths of maximum ultraviolet (UV) absorbance for isonicotinic acid and niacin are 270 and 260 nm, respectively. The amount of impurity found in the niacin sample was 0.3%. Twelve formulations, including sustained-release products, one bulk material, and the United States Pharmacopeia (USP) reference standard were tested. The impurity was detected in only the bulk and USP reference material samples.
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Medina-López J R, Sánchez-Badajos S, Carreto-Jiménez R M, García-Hernández P, and Contreras-Jiménez J M. "Comparative in vitro dissolution studies of fixed-dose combination formulations: analgesic tablets of acetaminophen/caffeine." International Journal of Research in Pharmaceutical Sciences 12, no. 2 (April 7, 2021): 1063–73. http://dx.doi.org/10.26452/ijrps.v12i2.4634.
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A simple and rapid UV derivative method with zero-crossing determinations was developed for estimation of acetaminophen (ACE) and caffeine (CAF) in fixed-dose combination formulations. The first-derivative of standard solutions of both drugs were used and ACE and CAF were quantified at 273.0 and 216.5 nm, respectively. The method was validated, and it was applied to dissolution studies with the USP Apparatus 2 and flow-through cell (USP Apparatus 4). Dissolution profiles comparisons (generic vs reference) were carried out with model-independent and model-dependent approaches. Mean dissolution time and dissolution efficiency were calculated and significant differences, in almost all calculated parameters, were found (p<0.05). Weibull, logistic, Gompertz, and Probit models were used to fit dissolution data and Probit was the best-fit model that describes the in vitro dissolution performance of ACE and CAF. Using t50% data, derived from this fit, dissolution profiles of ACE in USP Apparatus 2 were significant different (p<0.05). The proposed UV derivative method generates reliable information that can be compared with published results. Dissolution studies of fixed-dose combination formulations are important because quality of generic drug products depends on quality of references. It is essential to maintain a post-marketing evaluation of formulations with analgesic drugs mixed with CAF to offer the population high quality medicines.
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Plowman, Sharon Ann. "Criterion Referenced Standards for Neurornuscular Physical Fitness Tests: An Analysis." Pediatric Exercise Science 4, no. 1 (February 1992): 10–19. http://dx.doi.org/10.1123/pes.4.1.10.
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This paper analyzes the determination of the criterion referenced standards for the neuromuscular physical fitness items (sit-ups, sit-and-reach, and pullups) typically included in health related physical fitness test batteries for children and adolescents. Criterion referenced standards should be linked to some specific status on a health criterion that represents an absolute desirable level of that characteristic. Three techniques used to determine and/or validate criterion referenced standards are discussed: the use of empirical data with an established criterion test, the use of empirical data with instructed versus uninstructed groups, and the use of normative data and expert judgment. It is concluded that the existing criterion referenced standards have been derived exclusively from normative data and expert opinion. It remains unknown as to the meaning of these standards in relation to desirable and absolute levels of health.
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Lee, Dong Ho, Jae Young Lee, Min Sun Park, and Joon Koo Han. "Non-invasive monitoring of hepatic steatosis via acoustic structure quantification of ultrasonography with MR spectroscopy as the reference standard." Ultrasonography 39, no. 1 (January 1, 2020): 70–78. http://dx.doi.org/10.14366/usg.19002.
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Darusman, Latifah K., Mohamad Rafi, Wulan Tri Wahyuni, and Rizna Azrianiningsari. "FIRST-ORDER ULTRAVIOLET DERIVATIVE SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF RESERPINE IN ANTIHYPERTENSION TABLET." Indonesian Journal of Chemistry 12, no. 3 (December 28, 2012): 268–72. http://dx.doi.org/10.22146/ijc.21341.
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A new ultraviolet derivative spectrophotometry (UVDS) method has been developed for determination of reserpine in antihypertension tablets. A first-order UVDS based on the measurement of the distance between peaks to baseline (DZ) at the wavelength of 312 nm was used. Evaluation of analytical performance showed that accuracy as percentage recovery was 99.18-101.13%, precision expressed as relative standard deviation (RSD) was 1.91% and linear correlation was also obtained 0.9998 in the range of 10-50 µg/mL. Estimation of limit of detection and limit of quantitation was 0.8868 µg/mL and 2.6874 µg/mL, respectively. As a reference method, HPLC methods from United States Pharmacopiea (USP) were used. Commercially tablets available were analyzed by the two methods. The content of reserpine in tablets was found 0.2260±0.0033 mg by UVDS and 0.2301±0.0051 mg by the USP methods. The result obtained from the two methods was compared statistically using F-test and t-test and showed no significant differences between the variance and mean values of the two methods at 95% confidence level. This method was faster, easier, low cost and gave result as well as the reference method published by USP.
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Hauck, Walter W. "Establishing Acceptance Limits for Dissolution Performance Verification of USP Apparatus 1 and 2 Using USP Prednisone Tablets Reference Standard Lot Q0H398." Dissolution Technologies 20, no. 1 (2013): 6–11. http://dx.doi.org/10.14227/dt200113p6.
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Merton, R. E., A. D. Curtis, and D. P. Thomas. "A Comparison of Heparin Potency Estimates Obtained by Activated Partial Thromboplastin Time and British Pharmacopoeial Assays." Thrombosis and Haemostasis 53, no. 01 (1985): 116–17. http://dx.doi.org/10.1055/s-0038-1661248.
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SummaryHeparin samples from five manufacturers were assayed by the revised British Pharmacopoeia (BP) heparin assay and the results compared with those obtained using the activated partial thromboplastin time (APTT) assay. The United States Pharmacopeia (USP) reference heparin preparation and the 4th International Standard (IS) for heparin were also assayed by the two methods relative to the 3rd IS. The results obtained by the revised BP assay were in close agreement with those obtained by the APTT assay for all the heparins that were tested. The assays revealed that there is at least a 10% discrepancy between the International Unit for heparin and the USP unit.
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Jeon, Sun Kyung, Ijin Joo, So Yeon Kim, Jong Keon Jang, Juil Park, Hee Sun Park, Eun Sun Lee, and Jeong Min Lee. "Quantitative ultrasound radiofrequency data analysis for the assessment of hepatic steatosis using the controlled attenuation parameter as a reference standard." Ultrasonography 40, no. 1 (January 1, 2021): 136–46. http://dx.doi.org/10.14366/usg.20042.
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Chen, Pei, Fenhong Song, and Long-Ze Lin. "Chromatographic Fingerprint Analysis of Pycnogenol® Dietary Supplements." Journal of AOAC INTERNATIONAL 92, no. 2 (March 1, 2009): 624–32. http://dx.doi.org/10.1093/jaoac/92.2.624.
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Abstract The bark of maritime pine (Pinus pinaster Aiton) has been widely used as a remedy for various degenerative diseases. A standard high-performance liquid chromatographic (HPLC) procedure for Pycnogenol® analysis is a method specified in the United States Pharmacopeia (USP) monograph, which requires measurement of peak areas and identification of four components of the extract: caffeic acid, catechin, ferulic acid, and taxifolin. In this study, a fingerprint analysis using an HPLC method based on the USP monograph has been developed to provide additional qualitative information for the analysis of Pycnogenol-containing dietary supplements (PDS). Twelve commercially available PDS samples were purchased and analyzed along with a standard Pycnogenol extract. Their chromatographic fingerprints were analyzed using principal component analysis. The results showed that two of the samples were not consistent with the standard reference Pycnogenol extract. One contained other active ingredients in addition to Pycnogenol, and the other may have resulted from a quality control issue in manufacturing.
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Lefebvre, Fabien, M. Francois, J. Cacot, C. Hemery, P. Le-Bec, E. Baumhauer, Denis Bouscaud, et al. "External Reference Samples for Residual Stress Analysis by X-Ray Diffraction." Materials Science Forum 681 (March 2011): 215–22. http://dx.doi.org/10.4028/www.scientific.net/msf.681.215.
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The GFAC (French Association for residual stress analysis) decided in 2007 to work on external reference samples for residual stress analysis by X-ray diffraction as defined in the XPA 09-285 and EN 15305-2009 standards. Seven materials are studied: ferritic steel, martensitic steel, aluminium alloy, titanium alloy, 2 types of Nickel-Chromium alloy and tungsten thin layers deposited on silicon wafers. The purpose of this external round robin campaign is threefold: (i) to give possibilities for each laboratory involved in the campaign test to obtain external reference samples for each material tested, (ii) to validate a common procedure for qualification of external samples and (iii) to commercialise validated external reference samples through the GFAC association. A common approach of X-Ray diffraction parameters, samples geometry and standard procedure has been chosen and adopted by each laboratory involved in these tests. No indication in terms of residual stress calculation method is given; the choice of the method (centroid, middle point, maximum of peak, fitting…) is the choice of the laboratory according to their X-ray diffraction set-ups, softwares and experience. Once all samples are analysed, values given by each laboratory are compared and analysed.
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Ângelo, Marilene, Jennifer Jacon, Olimpia Maria Santos, Edith Cristina Cazedey, Rudy Bonfilio, Antônio Carlos Doriguetto, and Magali Benjamim de Araújo. "Occurrence of polymorphism in famotidine raw materials." Acta Crystallographica Section A Foundations and Advances 70, a1 (August 5, 2014): C1563. http://dx.doi.org/10.1107/s2053273314084368.
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Polymorphs are compounds with the same chemical composition, however the molecules are arranged in at least two different ways in the solid state. Famotidine is a histamine H2-receptor antagonist inhibitor of gastric secretion and widely used in gastric and duodenal ulcer disease. Two polymorphs are described for famotidine, A and B. The polymorph A is the most thermodynamically stable form and polymorph B is the kinetically favored form being marketed because it presents greater pharmacological activity. The aim of this study was to evaluate the occurrence of famotidine polymorphs in five raw materials acquired from different suppliers. The reference standard (USP) was also analyzed. All samples were characterized by powder X-ray diffraction (PXRD), infrared spectrophotometry (IR-ATR) and differential scanning calorimetry (DSC). PXRD analysis enables us to identify form B in five raw material samples and in the reference standard (USP). However, one of the raw materials additionally shows the presence of polymorphic form A. The DSC and IR-ATR techniques were essential to identify the polymorphic forms of famotidine confirming the results obtained by PXRD. Since the presence of polymorphs can compromise the effectiveness and safety of medicines and there is no official methodology of analysis and control of polymorphism in famotidine raw materials, the polymorphic contamination found in this study are being further analyzed and their physicochemical properties are being evaluated.
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Kouta, Ahmed, Walter Jeske, Rick Duff, Debra Hoppensteadt, Omer Iqbal, and Jawed Fareed. "USP Potency Adjusted Bovine Mucosal Heparins (BMH) Are Comparable to Porcine Mucosal Heparin (PMH) at Equivalent Levels." Blood 134, Supplement_1 (November 13, 2019): 165. http://dx.doi.org/10.1182/blood-2019-131943.
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Introduction: Unfractionated heparin (UFH) remains to be the only parenteral anticoagulant used in the management of various thrombotic disorders such as deep vein thrombosis (DVT), pulmonary embolism (PE), and cardiovascular interventions. Most of the heparins used clinically are derived from porcine intestinal mucosa. There is likelihood of supply shortage of this important anticoagulant which is crucial for hemodialysis, cardiopulmonary bypass surgery and other vascular interventions. BMH are currently being developed for re-introduction for both medical and surgical indications. In contrast to the PMH, the active pharmaceutical ingredient (API) of BMH exhibit a somewhat weaker USP potency as cross-referenced against PMH. We hypothesized that at equivalent potencies as adjusted by using the USP reference, the BMH may exhibit comparable in vitro and in vivo effects. Therefore, in vitro and in vivo studies were used to compare the APIs of the bovine (140 U/mg) and the PMH (190 U/mg) to demonstrate their bioequivalence. Materials and Methods: API versions of PMH (190 U/mg) were obtained from Celsus Laboratories (Franklin, OH). API versions of BMH (140 U/mg) were obtained from KinMaster (Paso Fundo, Brazil). Each of these heparins was assayed for their molecular weight profile, AT affinity, USP potency, protamine and platelet factor 4 neutralization and anticoagulant/antiprotease profiles using standard laboratory methods. In the primate studies, potencies of each heparin were determined by amidolytic anti-Xa assay in relation to the USP heparin standard. Individual groups of primates (n=4) were administered 100 anti-Xa U/kg doses of bovine or porcine heparin via intravenous route. Blood samples were collected prior to dosing and at 15-, 30-, 60- and 120-minutes post-administration. Anti-Xa and anti-IIa activities were measured to determine circulating heparin concentrations using commercially available USP compliant kits (Aniara Diagnostica, West Chester, OH). These drug concentrations were used to determine pharmacokinetic parameters such as area under the curve (AUC), half-life (t1/2), clearance (Cl) and volume of distribution (Vd) using the PKSolver add-in for Excel. Results: BMH exhibited higher molecular weight profiles compared to PMH as determined by size exclusion chromatography (BMH (Mw) 18.6 ± 0.5 kDa and PMH 15.4 ± 0.4 kDa). BMH exhibited a potency of 140 U/mg and PMH had a potency of 195 U/mg. In the anticoagulant and antiprotease assays, the BMH exhibited lower functionality which was proportional to USP potency. In vitro, when the BMH was compared at a potency adjusted concentration with PMH, it showed identical calibration curves in the aPTT and anti-protease assays. However, in the protamine neutralization and platelet factor 4 studies, BMH required slightly higher amounts of the agents in contrast to PMH. The concentration vs. time curves for both heparins were almost superimposable. Peak drug levels of approximately 1.5 and 1.4 U/mL were measured using anti-Xa and anti-IIa assays, respectively. After 2 hours, circulating drug levels were decreased to approximately 0.4 U/mL for all heparins. Pharmacokinetic parameters calculated from plasma concentration-time curves indicated that both heparins behaved similarly. Mean half-life based on anti-Xa activity ranged from 54 ± 11 min for porcine heparin to 71 ± 18 min for bovine heparin. Slightly longer half-lives were observed using plasma concentrations determined using anti-IIa activity. Mean AUC values based on anti-Xa or anti-IIa activities were comparable for both heparins. Mean Vd (~60 ml/kg) and Cl (~0.75 ml/kg/min) were also comparable for both heparins. Conclusion: In vitro, BMH at adjusted biologic potency is comparable to PMH, however, it requires proportionally higher amount of protamine and platelet factor 4 due to the increased mass for adjusting to higher potency. In the non-human primates, USP cross-referenced anti-Xa potency adjusted based dosing results in comparable pharmacokinetic profiles for bovine and porcine heparins. Therefore, such dosing may provide uniform levels of anticoagulation for the parenteral indications for heparins. These observations warrant clinical validations in the specific indications. Disclosures No relevant conflicts of interest to declare.
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한재필. "Standard for Examination of Documents under UCP 600 -with a Special Reference to Related Rules of UCP 500." KOREA INTERNATIONAL COMMERCIAL REVIEW 22, no. 2 (June 2007): 107–25. http://dx.doi.org/10.18104/kaic.22.2.200706.107.
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Solon, Lílian Grace da Silva, Ana Isabel Maia de Oliveira, Gerlane Coelho Bernardo Guerra, Luiz Alberto Lira Soares, and Aurigena Antunes de Araújo. "Determination of carbamazepine in pharmaceutical formulations." Brazilian Journal of Pharmaceutical Sciences 46, no. 3 (September 2010): 509–13. http://dx.doi.org/10.1590/s1984-82502010000300014.
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The aim of this study was to evaluate the quality of five different solid formulations of carbamazepine. The reference formulation was Tegretol® 200.00 mg (Novartis) and the others were: generic formulation of carbamazepine 200.00 mg (National Industry), similar formulation of carbamazepine 200.00 mg (National Industry), and two formulations of carbamazepine 200.00 mg acquired from two different compounding pharmacies. The latter consisted of capsules obtained in Natal, the capital city of the Brazilian State of Rio Grande do Norte. The quality of samples was evaluated through physical and physical-chemical tests, including: weight, diameter, thickness, content, dissolution, disintegration, hardness, friability and moisture. The results of friability analysis showed that all formulations met Brazilian and United States Pharmacopeia (USP) specifications. In spite of having a higher hardness compared to the reference, the generic formulation had a lower disintegration time. This could be associated to the presence of crospovidone in its formulation. Results of this study showed that all formulations had dissolutions which were in accordance with Brazilian Pharmacopoeia specifications, and quality control tests. An exception was found for the similar formulation, which had a hardness parameter that exceeded the USP standard. However, this difference was not significant given the similar formulation's satisfactory disintegration time.
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Isaacson, Glenn, Bettina A. Buttaro, Valorie Mazeffa, Geming Li, and Dorothy A. Frenz. "Oxymetazoline Solutions Inhibit Middle Ear Pathogens and are Not Ototoxic." Annals of Otology, Rhinology & Laryngology 114, no. 8 (August 2005): 645–51. http://dx.doi.org/10.1177/000348940511400811.
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Objectives: This study was performed to explore the antimicrobial activity of two commercially available oxymetazoline hydrochloride preparations against the common pathogens of otitis media and to demonstrate the lack of ototoxicity of these agents and of United States Pharmacopeia (USP) oxymetazoline in a standard animal model. Methods: Disc diffusion assays and minimum inhibitory concentration studies against American Type Culture Collection reference strains of common middle ear pathogens were used to evaluate the antimicrobial activity of oxymetazoline solutions and fluoroquinolone drops, and outer hair cell counts were performed on scanning electron micrographs of guinea pig basal cochlear segments after chronic exposure to oxymetazoline solutions and positive and negative controls. Results: Oxymetazoline nasal spray and eyedrops had activity against all species tested except Haemophilus influenzae and Pseudomonas aeruginosa. The USP oxymetazoline had limited antimicrobial activity. Oxymetazoline nasal spray, oxymetazoline eyedrops, and USP oxymetazoline had ototoxicity profiles indistinguishable from that of the saline solution control. Conclusions: Commercially available oxymetazoline solutions are active against several of the common pathogens of otitis media. This antimicrobial activity is not due to oxymetazoline, and is more likely due to preservatives present in the solutions. The solutions tested are not ototoxic to guinea pig outer hair cells. Oxymetazoline solutions are potential substitutes for broad-spectrum antibiotic drops after tympanostomy tube placement.
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Araújo, Adriano Antunes Souza, Marília dos Santos Bezerra, Sílvia Storpirtis, and Jivaldo do Rosário Matos. "Determination of the melting temperature, heat of fusion, and purity analysis of different samples of zidovudine (AZT) using DSC." Brazilian Journal of Pharmaceutical Sciences 46, no. 1 (March 2010): 37–43. http://dx.doi.org/10.1590/s1984-82502010000100005.
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The determination of chemical purity, melting range, and variation of enthalpy in the process of characterizing medicines is one of the principal requirements evaluated in quality control of the pharmaceutical industry. In this study, the method of purity determination using DSC was outlined, as well as the application of this technique for the evaluation of commercial samples of zidovudine (AZT) (raw material) supplied by different laboratories. To this end, samples from six different laboratories (A, B, C, D, E, and F) and the standard reference (R) from the United States Pharmacopeia (USP) were analyzed. The DSC curves were obtained in the temperature range of 25 to 200 ºC under the dynamic atmosphere of N2 (50 mL min-1), heating rate of β=2 ºC min-1, using an Al capsule containing approximately 2 mg of sample material. The results demonstrated that the standard reference presented a proportion of 99.83% whereas the AZT samples presented a variation ranging from 97.59 to 99.54%. In addition, the standard reference was found to present a temperature of onset of melting point of 122.80 °C. Regarding the samples of active agents provided by the different laboratories, a variation ranging from 118.70 to 122.87 °C was measured. In terms of ΔHm, the samples presented an average value of 31.12 kJ mol-1.
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Wadhwa, Aparna, Faraat Ali, Sana Parveen, Robin Kumar, and Gyanendra N. Singh. "Synthesis, Analytical Characterization and Spectroscopic Investigation of Chloramphenicol Impurity A for the Quality Control of Chloramphenicol and its Formulation as Per International Compendium." Current Organic Synthesis 17, no. 5 (July 27, 2020): 382–88. http://dx.doi.org/10.2174/1570179417666200410170237.
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Objective: The main aim of the present work is to synthesize chloramphenicol impurity A (CLRMIMP- A) in the purest form and its subsequent characterization by using a panel of sophisticated analytical techniques (LC-MS, DSC, TGA, NMR, FTIR, HPLC, and CHNS) to provide as a reference standard mentioned in most of the international compendiums, including IP, BP, USP, and EP. The present synthetic procedure has not been disclosed anywhere in the prior art. Methods: A simple, cheaper, and new synthesis method was described for the preparation of CLRM-IMP-A. It was synthesized and characterized by FTIR, DSC, TGA, NMR (1H and 13C), LC-MS, CHNS, and HPLC. Results: CLRM-IMP-A present in drugs and dosage form can alter the therapeutic effects and adverse reaction of a drug considerably, it is mandatory to have a precise method for the estimation of impurities to safeguard the public health. Under these circumstances, the presence of CLRM-IMP-A in chloramphenicol (CLRM) requires strict quality control to satisfy the specified regulatory limit. The synthetic impurity obtained was in the pure form to provide a certified reference standard or working standard to stakeholders with defined potency. Conclusion: The present research describes a novel technique for the synthesis of pharmacopoeial impurity, which can help in checking/controlling the quality of the CLRM in the international markets.
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Kirgiz, Mehmet Serkan. "Effects of Blended-Cement Paste Chemical Composition Changes on Some Strength Gains of Blended-Mortars." Scientific World Journal 2014 (2014): 1–11. http://dx.doi.org/10.1155/2014/625350.
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Effects of chemical compositions changes of blended-cement pastes (BCPCCC) on some strength gains of blended cement mortars (BCMSG) were monitored in order to gain a better understanding for developments of hydration and strength of blended cements. Blended cements (BC) were prepared by blending of 5% gypsum and 6%, 20%, 21%, and 35% marble powder (MP) or 6%, 20%, 21%, and 35% brick powder (BP) for CEMI42.5N cement clinker and grinding these portions in ball mill at 30 (min). Pastes and mortars, containing the MP-BC and the BP-BC and the reference cement (RC) and tap water and standard mortar sand, were also mixed and they were cured within water until testing. Experiments included chemical compositions of pastes and compressive strengths (CS) and flexural strengths (FS) of mortars were determined at 7th-day, 28th-day, and 90th-day according to TS EN 196-2 and TS EN 196-1 present standards. Experimental results indicated that ups and downs of silica oxide (SiO2), sodium oxide (Na2O), and alkali at MP-BCPCC and continuously rising movement of silica oxide (SiO2) at BP-BCPCC positively influenced CS and FS of blended cement mortars (BCM) in comparison with reference mortars (RM) at whole cure days as MP up to 6% or BP up to 35% was blended for cement.
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Cintra, Jorge Pimentel, Marcelo Antonio Nero, and Danilo Rodrigues. "GNSS/NTRIP service and technique: accuracy tests." Boletim de Ciências Geodésicas 17, no. 2 (June 2011): 257–71. http://dx.doi.org/10.1590/s1982-21702011000200006.
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Experiments conducted at the School of Engineering of the University of São Paulo, Brazil, using GNSS/NTRIP technology are described and analyzed in terms of accuracy. The method consists in using the data of a reference station, the IBGE RBMC-IP stations, collected in a remote station, by means of the Internet and a mobile phone, to obtain more accurate real time coordinates than those of the navigation method. The experiments consist in surveying the known coordinate points and of the error analysis (accuracy). Firstly with short distances (in the USP Base for Equipment Calibration), and then over increasing distances up to about 30 km, in terms of the limits foreseen for the RTK method, and for other greater distances by using the DGPS method, up to 2,700 km. The following were tested and analyzed: the use of different reference stations, the variation in accuracy over distance, the use of a L1 receiver and a L1/L2 one, as well as the use of the RTK and DGPS techniques, in terms of accuracy reached, that is, the difference between these coordinates and others considered as standard, besides checking if the equipment reaches or not the accuracy stated in the manual.
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Gonzalez-Alvarez, Isabel, Marival Bermejo, Yasuhiro Tsume, Alejandro Ruiz-Picazo, Marta Gonzalez-Alvarez, Bart Hens, Alfredo Garcia-Arieta, Greg E. Amidon, and Gordon L. Amidon. "An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products." Pharmaceutics 13, no. 4 (April 7, 2021): 507. http://dx.doi.org/10.3390/pharmaceutics13040507.
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The purpose of this study was to predict in vivo performance of three oral products of Etoricoxib (Arcoxia® as reference and two generic formulations in development) by conducting in vivo predictive dissolution with GIS (Gastro Intestinal Simulator) and computational analysis. Those predictions were compared with the results from previous bioequivalence (BE) human studies. Product dissolution studies were performed using a computer-controlled multicompartmental dissolution device (GIS) equipped with three dissolution chambers, representing stomach, duodenum, and jejunum, with integrated transit times and secretion rates. The measured dissolved amounts were modelled in each compartment with a set of differential equations representing transit, dissolution, and precipitation processes. The observed drug concentration by in vitro dissolution studies were directly convoluted with permeability and disposition parameters from literature to generate the predicted plasma concentrations. The GIS was able to detect the dissolution differences among reference and generic formulations in the gastric chamber where the drug solubility is high (pH 2) while the USP 2 standard dissolution test at pH 2 did not show any difference. Therefore, the current study confirms the importance of multicompartmental dissolution testing for weak bases as observed for other case examples but also the impact of excipients on duodenal and jejunal in vivo behavior.
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Ono, Akihiro, Masao Saeki, and Koichi Chiba. "Direct Analysis of Solid Sample with Ultrafine Particle Generation/Inductively Coupled Plasma Emission Spectroscopy." Applied Spectroscopy 41, no. 6 (August 1987): 970–76. http://dx.doi.org/10.1366/0003702874447941.
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An ultrafine particle generation (UFP) system has been developed for the direct analysis of solid metal samples by inductively coupled plasma (ICP) emission spectrometry. In this system fine particles are generated from solid samples with the use of a spark discharge and then swept into the ICP. The spark discharge conditions involving the electrode gap and the analytical performance of the ICP system are investigated. Analytical calibration curves are presented for steel samples. The NBS standard reference materials are analyzed by the proposed system.
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Hobold, Edilson, Vitor Pires-Lopes, Rossana Gómez-Campos, Miguel de Arruda, Cynthia Lee Andruske, Jaime Pacheco-Carrillo, and Marco Antonio Cossio-Bolaños. "Reference standards to assess physical fitness of children and adolescents of Brazil: an approach to the students of the Lake Itaipú region—Brazil." PeerJ 5 (November 30, 2017): e4032. http://dx.doi.org/10.7717/peerj.4032.
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Background The importance of assessing body fat variables and physical fitness tests plays an important role in monitoring the level of activity and physical fitness of the general population. The objective of this study was to develop reference norms to evaluate the physical fitness aptitudes of children and adolescents based on age and sex from the lake region of Itaipú, Brazil. Methods A descriptive cross-sectional study was carried out with 5,962 students (2,938 males and 3,024 females) with an age range of 6.0 and 17.9 years. Weight (kg), height (cm), and triceps (mm), and sub-scapular skinfolds (mm) were measured. Body Mass Index (BMI kg/m2) was calculated. To evaluate the four physical fitness aptitude dimensions (morphological, muscular strength, flexibility, and cardio-respiratory), the following physical education tests were given to the students: sit-and-reach (cm), push-ups (rep), standing long jump (cm), and 20-m shuttle run (m). Results and Discussion Females showed greater flexibility in the sit-and-reach test and greater body fat than the males. No differences were found in BMI. Percentiles were created for the four components for the physical fitness aptitudes, BMI, and skinfolds by using the LMS method based on age and sex. The proposed reference values may be used for detecting talents and promoting health in children and adolescents.
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Ulanova, T. S., O. V. Gileva, E. V. Stenno, and G. A. Veikhman. "Peculiarities of vanadium determination in whole blood by icp-ms." Biomeditsinskaya Khimiya 60, no. 1 (January 2014): 109–14. http://dx.doi.org/10.18097/pbmc20146001109.
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The parameters of vanadium determination by ICP-MS in whole blood are presented. Conditions for blood sample preparation to reduce measure errors and to determine vanadium at the reference concentration level were optimized. The accuracy of the results is confirmed by analysis of standard blood samples Seronorm L1, L2 and L3. Vanadium mean in whole blood for the group of children from the town of Chusovoy (n=80) was 1.29±0.45 µg/L, and vanadium mean for grown – ups from the town of Chusovoy was 1.63±0.25 µg/L.
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Lisik, Anna, Dorota Wojcik-Pastuszka, Maria Twarda, Ryszard Berkowski, and Witold Musial. "Effect of standard and reversible arrangements of Ph.Eur./USP extraction cells during dissolution tests of calcium dobesilate in hydrogel formulation." Current Issues in Pharmacy and Medical Sciences 28, no. 2 (June 1, 2015): 136–42. http://dx.doi.org/10.1515/cipms-2015-0060.
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Abstract The aim of the study was to evaluate, in comparison to the reference product, the effect of the hydrophilic nonionic polymers: methylcellulose (MC) and hydroxypropyl methylcellulose (HPMC), as well as the anionic polymers - copolymers of acrylic acid, on the release kinetics of a calcium dobesilate hydrogel formulation intended for application on the skin. In this work, we used an ointment cell for the release of the active pharmaceutical ingredient (API) from the formulations. This release was performed by employing the paddle method at 100 rpm, with the extraction cells placed in the release vessels in two different positions: with the semipermeable membrane faced to the top, or to the bottom of the vessel. Released API percentage was assessed via the validated spectrophotometric method. In the study with standard placement of the ointment cell, the release rates ranged from 4.45×10-3 min-1 for a formulation containing polyacrylic acid (PA), to 6.96 × 10-3 min-1 for a formulation based on HPMC. In the group of nonionic polymers, the release rate is higher in the case of HPMC, and lower in the case of MC. In the group of anionic polymers, the release rate is higher with the formulation of a modified copolymer of acrylic acid 11 (PC11), while release from a formulation comprising a polymer PA is rather prolonged. We found that the placement of the extraction cell does not affect the alignment of the formulations investigated in terms of the release rates in the group of non-ionic formulations: HPMC > MC, and in the group of preparation of ionic polymers: PC11 > PA.
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Barrett, Douglas E. "Acoustical Acceptance Testing of Portland (Oregon) International Airport Ground Run-Up Enclosure." Transportation Research Record: Journal of the Transportation Research Board 1859, no. 1 (January 2003): 38–44. http://dx.doi.org/10.3141/1859-05.
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The Port of Portland constructed an aircraft ground run-up enclosure (GRE) at Portland International Airport (PDX) to allow unrestricted daytime and nighttime aircraft maintenance run-ups while complying with Oregon Department of Environmental Quality (DEQ) standards for community noise levels. To ensure compliance with the DEQ standards, a rigorous acoustical acceptance testing specification was developed and implemented. The PDX specification included measurements of three representative aircraft run-ups conducted at the GRE site (i.e., with GRE) and at a nearby equivalent site (i.e., without GRE). At each test site, measurements were required at six microphone locations at a reference distance of 400 ft (120 m) from the test aircraft, where variability in measured sound levels due to meteorological conditions would be limited. Although not part of the official acceptance test, simultaneous measurements were conducted in representative community locations as the start of ongoing community monitoring to be conducted by the Port of Portland. In April 2001, the GRE met the acoustical acceptance testing specifications and demonstrated compliance with the DEQ community requirements. The multiple-microphone arrays displayed the significant effect of noise shielding provided by aircraft fuselages and suggested that modifications may be appropriate for future applications of the test procedure.
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Niemi, Kristin, Siobhan Geary, Mark Larrabee, and Kevin R. Brown. "Standardized Vasoactive Medications: A Unified System for Every Patient, Everywhere." Hospital Pharmacy 40, no. 11 (November 2005): 984–93. http://dx.doi.org/10.1177/001857870504001108.
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Providing medications used in emergency cardiovascular care (ECC) in an efficient and consistent manner is a cornerstone for achieving excellent patient care and safety. For neonatal, pediatric, and adult patients who move through different specialty areas in a tertiary hospital, it is essential to have a standardized protocol for these medications that can be followed regardless of location or practitioner. Our institution developed a protocol for intravenous push (IVP) and continuous infusion (CI) medications based on the Neonatal Resuscitation Program (NRP), Pediatric Advanced Life Support (PALS) and Advanced Cardiovascular Life Support (ACLS) guidelines. This protocol incorporates these guidelines into a single reference sheet (Emergency Drug Sheet) based on the patient's weight using a computer software program. The program provides the option for either pediatric (weight-based) or adult (weight-based and standard dose) dosing. The CI section uses a limited number of concentrations, which meets the JCAHO mandate. Commercially available products are used, when possible, in response to USP <797>. It also serves as the standard protocol for vasoactive medications in all patient care settings in conjunction with programmable infusion pump technology. The software program is easy to use; the Emergency Drug Sheet is easy to read; and the program is available everywhere in the hospital. The standard CI protocol used with the Emergency Drug Sheet reduces unclear orders, standardizes drug preparation, and decreases the time to medication delivery. It could serve as a model for community hospitals, as well as tertiary facilities.
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Chang, Cheng-Chieh, Thakkar Chandni Hirenkumar, and Chin-Kuo Wu. "The Concept of Ocean Sustainability in Formal Education—Comparative Ocean Literacy Coverage Analysis of the Educational Standards of India and the USA." Sustainability 13, no. 8 (April 13, 2021): 4314. http://dx.doi.org/10.3390/su13084314.
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The concept of marine environmental sustainability is essential, and ocean literacy is currently at the core of its development. Comparing ocean literacy principles in curriculum standards is an important thing to do. Ocean literacy (OL) is a key and emerging topic, and its study has adopted a qualitative approach and follows the content analysis approach. It was observed that, on average, OL concepts covered in the educational standards of the USA (Next Generation Science Standards, NGSS) are higher than those of India (Indian National Standards, INSs). The study revealed that the 6th principle is highly accentuated in both countries’ educational standards out of the seven essential principles. Moreover, the results indicate variation in OL alignment across India’s grade bands and the USA’s educational standards. Based on the results mentioned above, the proposed study intends to provide references to marine education researchers, curriculum developers, and educational policymakers in India to suitably adjust OL coverage concepts in schools to cultivate ocean-literate citizens.
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APPELDOORN, RICHARD S. "Transforming reef fisheries management: application of an ecosystem-based approach in the USA Caribbean." Environmental Conservation 35, no. 3 (September 2008): 232–41. http://dx.doi.org/10.1017/s0376892908005018.
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SUMMARYFisheries in Puerto Rico and the United States (US) Virgin Islands are predominately dependent on nearshore coral reef ecosystems and have suffered from historical overfishing. The unique characteristics of reef fisheries, including strong habitat dependence, susceptibility to coastal impacts, diffuse landing sites and strong multispecies and multigear interactions suggest that standard approaches to fisheries management, especially those typically considered by the US Regional Fishery Management Councils, would not be applicable. Current management authority is split between local and federal agencies; however, there exists no uniform context and direction to current management initiatives, which results in lost efficiencies and opportunities. Proposed here is a new vision for fisheries management that takes into consideration the local ecological and socioeconomic characteristics of fishing, is compatible with regional resources and capacity, is ecosystem based and targets full stakeholder participation. Only an ecosystem-based approach can lead fisheries management out of the trap of unrealistic data collection and analysis demands, while at the same time refocusing emphasis away from attitudes and practices that promote overfishing. Management must be based on first principles regarding the desired state of the ecosystem and initiate strategies based on these principles. The key management goal is not to maximize fisheries catch, but to maintain the ecosystem in a state that will lead to sustained production. First principles would include maintaining ecosystem integrity and function, protecting all habitats and water quality, applying the precautionary approach, monitoring reference points and recognizing that production has limits. Resulting management tactics include marine reserves (to meet multiple goals), closed spawning aggregations, gear restrictions to maintain trophic balance and habitats, targeted data collection and assessments, adopting co-management practices and using ecosystem or community-based metrics. Fisheries management must fully incorporate the tools, resources and methods available within coastal zone management and other environmental agencies, while standards within those programmes must protect ecosystem health. Implementation will require attending to structural barriers inherent within existing fisheries legislation and regulations, multiple jurisdictions and the current cultures of scientists, managers and fisherfolk. Initial efforts should focus on developing a common language and frame of reference for all stakeholders.
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Ali, Tariq, Muhammad Harris Shoaib, Rabia Ismail Yousuf, Sabahat Jabeen, Iyad Naeem Muhammad, and Asfia Tariq. "Use of hydrophilic and hydrophobic polymers for the development of controlled release tizanidine matrix tablets." Brazilian Journal of Pharmaceutical Sciences 50, no. 4 (December 2014): 799–818. http://dx.doi.org/10.1590/s1984-82502014000400016.
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The aim of the present study was to develop tizanidine controlled release matrix. Formulations were designed using central composite method with the help of design expert version 7.0 software. Avicel pH 101 in the range of 14-50% was used as a filler, while HPMC K4M and K100M in the range of 25-55%, Ethylcellulose 10 ST and 10FP in the range of 15 - 45% and Kollidon SR in the range of 25-60% were used as controlled release agents in designing different formulations. Various physical parameters including powder flow for blends and weight variation, thickness, hardness, friability, disintegration time and in-vitro release were tested for tablets. Assay of tablets were also performed as specified in USP 35 NF 32. Physical parameters of both powder blend and compressed tablets such as compressibility index, angle of repose, weight variation, thickness, hardness, friability, disintegration time and assay were evaluated and found to be satisfactory for formulations K4M2, K4M3, K4M9, K100M2, K100M3, K100M9, E10FP2, E10FP9, KSR2, KSR3 & KSR9. In vitro dissolution study was conducted in 900 ml of 0.1N HCl, phosphate buffer pH 4.5 and 6.8 medium using USP Apparatus II. In vitro release profiles indicated that formulations prepared with Ethocel 10 standard were unable to control the release of drug while formulations K4M2, K100M9, E10FP2 & KSR2 having polymer content ranging from 40-55% showed a controlled drug release pattern in the above mentioned medium. Zero-order drug release kinetics was observed for formulations K4M2, K100M9, E10FP2 & KSR2. Similarity test (f2) results for K4M2, E10FP2 & KSR2 were found to be comparable with reference formulation K100M9. Response Surface plots were also prepared for evaluating the effect of independent variable on the responses. Stability study was performed as per ICH guidelines and the calculated shelf life was 24-30 months for formulation K4M2, K100M9 and E10FP2.
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Park, Jae-Hong, Youngbae B. Kim, Seung-Jae Hyun, Kyu-Bok Kang, and Pil-Sun Park. "Changes in Thoracic Kyphosis and Thoracolumbar Kyphosis in Asymptomatic Korean Male Subjects Aged >50 Years: Do They Progress Above T5, T10, T12, or L2?" Asian Spine Journal 14, no. 2 (April 30, 2020): 192–97. http://dx.doi.org/10.31616/asj.2019.0060.
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Study Design: Retrospective analysis of prospectively collected data.Purpose: To evaluate the natural progression of segmental kyphosis in thoracic and thoracolumbar spine with advancing age.Overview of Literature: To our knowledge, the evolution of segmental thoracic kyphosis (TK) in individuals aged >50 years has not been reported.Methods: Total 179 normal, asymptomatic Korean men were divided in to three groups (6th, 7th, and 8th decade) according to their age. Standard sagittal spinopelvic parameters, including TK and thoracolumbar kyphosis, were measured and subdivided into the following four segments: A (C7 upper end plate [UEP]–T5 UEP), B (T5 UEP–T10 UEP), C (T10 UEP–T12 lower end plate [LEP]), and D (T12 LEP–L2 LEP). These segments of the three study groups were analyzed.Results: In segment B, the segmental kyphosis of group 3 (20.2°±8.0°) showed a statistically larger value than that of group 1 (15.6°±6.8°) and group 2 (16.7°±8.8°) (p=0.017). In segment C, the segmental kyphosis of group 2 (12.9°±6.5°) and group 3 (12.2°±7.1°) showed statistically larger values than that of group 1 (9.5°±6.2°) (p=0.016). The A and D segments of the three groups were not significantly different.Conclusions: Increased TK was observed in the middle (segment B) and lower (segment C) thoracic segments in normal asymptomatic male subjects with age. The results from the natural progression of segmental kyphosis with age would provide baseline reference data to help surgeons choose the optimal point of the upper instrumented vertebra level for preventing proximal junctional kyphosis.
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Olvera, Hector A., Daniel Perez, Juan W. Clague, Yung-Sung Cheng, Wen-Whai Li, Maria A. Amaya, Scott W. Burchiel, Marianne Berwick, and Nicholas E. Pingitore. "The Effect of Ventilation, Age, and Asthmatic Condition on Ultrafine Particle Deposition in Children." Pulmonary Medicine 2012 (2012): 1–9. http://dx.doi.org/10.1155/2012/736290.
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Ultrafine particles (UFPs) contribute to health risks associated with air pollution, especially respiratory disease in children. Nonetheless, experimental data on UFP deposition in asthmatic children has been minimal. In this study, the effect of ventilation, developing respiratory physiology, and asthmatic condition on the deposition efficiency of ultrafine particles in children was explored. Deposited fractions of UFP (10–200 nm) were determined in 9 asthmatic children, 8 nonasthmatic children, and 5 nonasthmatic adults. Deposition efficiencies in adults served as reference of fully developed respiratory physiologies. A validated deposition model was employed as an auxiliary tool to assess the independent effect of varying ventilation on deposition. Asthmatic conditions were confirmed via pre-and post-bronchodilator spirometry. Subjects were exposed to a hygroscopic aerosol with number geometric mean diameter of 27–31 nm, geometric standard deviation of 1.8–2.0, and concentration of1.2×106particles cm−3. Exposure was through a silicone mouthpiece. Total deposited fraction (TDF) and normalized deposition rate were 50% and 32% higher in children than in adults. Accounting for tidal volume and age variation, TDF was 21% higher in asthmatic than in non-asthmatic children. The higher health risks of air pollution exposure observed in children and asthmatics might be augmented by their susceptibility to higher dosages of UFP.
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Cavezzi, Labropoulos, Partsch, Ricci, Caggiati, Myers, Nicolaides, and Smith. "Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs-UIP consensus document. Part II. Anatomy." Vasa 36, no. 1 (February 1, 2007): 62–71. http://dx.doi.org/10.1024/0301-1526.36.1.62.
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Background: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of anatomy of superficial and perforating veins in the lower limb by ultrasound imaging. Methods: The authors performed a systematic review of the published literature on duplex anatomy of the superficial and perforating veins of the lower limbs; afterwards they invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the authors and the experts (text and images) were made available to all participants via the UIP website. The authors prepared a draft document for discussion at the UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually, all participants agreed the final version of the paper. Results: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document provides a detailed methodology for complete ultrasound assessment of the anatomy of the superficial and perforating veins in the lower limbs. Conclusions: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography, with specific reference to the anatomy of the main superficial veins and perforators of the lower limbs in healthy and varicose subjects.
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Cavezzi, A., N. Labropoulos, H. Partsch, S. Ricci, A. Caggiati, K. Myers, A. Nicolaides, and P. Coleridge-Smith. "Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs – UIP Consensus Document. Part II: Anatomy." Phlebology: The Journal of Venous Disease 21, no. 4 (December 1, 2006): 168–79. http://dx.doi.org/10.1258/026835506779115799.
Full textAbstract:
Objectives: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of the anatomy of superficial and perforating veins in the lower limb by ultrasound imaging. Design: Consensus conference leading to a consensus document. Methods: The authors performed a systematic review of the published literature on duplex anatomy of the superficial and perforating veins of the lower limbs. Afterwards, they invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the authors and the experts (text and images) were made available to all participants via the UIP website. The authors prepared a draft document for discussion at the UIP Chapter meeting held in San Diego, USA, in August 2003. Following this meeting, a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually, all participants agreed on the final version of the paper. Results: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document provides a detailed methodology for complete ultrasound assessment of the anatomy of the superficial and perforating veins in the lower limbs. Conclusions: The authors and a large group of experts have agreed on a methodology for the investigation of the lower limbs venous system, by duplex ultrasonography, with specific reference to the anatomy of the main superficial veins and perforators of the lower limbs in healthy and varicose subjects.
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Bhadoria, Ashutosh, and Sanjay Marwaha. "Moth flame optimizer-based solution approach for unit commitment and generation scheduling problem of electric power system." Journal of Computational Design and Engineering 7, no. 5 (August 19, 2020): 668–83. http://dx.doi.org/10.1093/jcde/qwaa050.
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Abstract This paper proposes a new approach based on the moth flame optimizer algorithm. Moth flame optimizer simulates the natural fervent navigation technique adopted by moths looking for a source of light. The proposed method is further improved by priority list-based ordering; the unit commitment problem (UCP) is a non-linear, non-convex, and combinatorial complex optimization problem. It contains both continuous and discrete variables. This further increases its complexity. Moth flame optimizer is very good at obtaining a commitment pattern: allocation of power on the committed units obtained by mixed-integer quadratic programming method. Heuristic search strategies are used to adopt for the repair of minimum up and downtime, and spinning reserve constraints. MFO effectiveness is tested on the standard UCP reference IEEE model buses 14 and 30, and 10 and 20 units. The efficiency of the projected algorithms is compared to classical PSO, PSOLR, HPSO, PSOSQP, hybrid MPSO, IBPSO, LCA-PSO, NPSO, PSO-GWO, and various other evolutionary algorithms. The comparison result shows that MFO can lead to all methods reported earlier in literature.
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Casals, Elias, Tchilalo Boukpessi, Christina M. McQueen, Sandy L. Eversole, and Robert V. Faller. "Anticaries Potential of Commercial Dentifrices as Determined by Fluoridation and Remineralization Efficiency." Journal of Contemporary Dental Practice 8, no. 7 (2007): 1–10. http://dx.doi.org/10.5005/jcdp-8-7-1.
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Abstract Aim The aim of this in vitro study was to investigate fluoride uptake in human enamel after use of commercially available toothpastes containing different fluoride compounds, or combinations of fluoride actives formulated into a single product, as a means of determining the efficiency of each formula for delivering caries preventing fluoride to demineralized (caries active) enamel. Methods and Materials Four test dentifrices and two controls were assessed and placed in groups as follows: Group 1: Lacer® (Spain); Group 2: Positive control-USP Reference Standard 1100 ppm F; Group 3: Fluocaril® Bi-Fluoré 250 (France); Group 4: Colgate Fluor Active (Denmark); Group 5: Elmex® (France); and Group 6: A placebo (formulated the same as the USP Reference Standard toothpaste with the exception that it contained < 1 ppm F). Cores 3 mm in diameter were removed from erupted human enamel specimens (extracted by local oral surgeons for orthodontic reasons) and stored in 1% Thymol solution prior to use. They were ground and polished to remove the natural fluoride rich enamel layer, then exposed to a demineralization solution, and assessed for surface microhardness to enable randomization for use in the study. Each group of five specimens underwent a daily pH cycling procedure that involved exposure to pooled human saliva (refreshed three times daily). The groups were then exposed to dentifrice slurries four times daily for one minute per exposure and to a demineralization solution for three hours. The cycling procedure was repeated for five days. Specimens were again analyzed for surface microhardness and fluoride uptake upon completion of five days of treatment. Results Average surface hardness: Groups 2 and 3 showed a statistically significant greater (p<0.05) change indicating greater remineralization compared to all other groups. The average change was 23.45 for Group 2 and 22.65 for Group 3. All other groups had changes ranging from 4.25-8.62. No other statistically significant differences were observed between groups. Fluoride uptake results: Groups 2 and 3 showed statistically significantly greater fluoride uptake versus all other groups (p <0.05). Groups 1 and 5 were significantly different from Group 6. No other statistically significant differences were observed for either analysis. Conclusions Of the marketed products included in the study, the Fluocaril® Bi-Fluoré 250 product formulation provided both the highest level of fluoride uptake and mineralization to the demineralized enamel. The clinical significance of these in vitro results is the confirmation Fluocaril® Bi-Fluoré 250 is effective at remineralizing enamel caries lesions. Citation Casals E, Boukpessi T, McQueen CM, Eversole SL, Faller RV. Anticaries Potential of Commercial Dentifrices as Determined by Fluoridation and Remineralization Efficiency. J Contemp Dent Pract 2007 November; (8)7:001-010.
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Franklin, Scott B., Michael Scheibout, and Jozef Šibik. "Vegetation Classification Exercise for the Pawnee National Grasslands, USA." Vegetation Classification and Survey 1 (November 16, 2020): 123–37. http://dx.doi.org/10.3897/vcs/2020/38629.
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Aims: Vegetation classifications are useful for a variety of management purposes as well as scientific exploration. Local classifications are common throughout the United States but only recently have been integrated into a national classification system, which is now expected for local classifications. Study Area: The Pawnee National Grasslands (PNG) in northeastern Colorado, USA, has not been classified using plot data, and is thus a gap on the baseline knowledge of the PNG plant communities that hinders impact assessment of various anthropogenic activities. Methods: Here, we use 128 plots to classify the vegetation of the PNG using a two-step process: first, classifying the PNG plots alone to characterize local uniqueness, and then employing a semi-supervised classification with an additional 64 plots from areas to the north and east of the PNG, using standard classification procedures. Results: We document on the PNG the occurrence of two Classes, three Subclasses, four Formations, five Divisions, six Macrogroups, seven Groups and eight Alliances and Associations already described in the USNVC. Conclusions: The PNG is dominated by the Bouteloua gracilis-Buchloe dactyloides Grassland Association, which we further subdivide and describe as three local subassociations. The mixed-grass concepts in the USNVC do not exist in the PNG. Taxonomic reference: Hazlett (1998). Syntaxonomic reference: USNVC (2016). Abbreviations: BLM = Bureau of Land Management; CPER = Central Plains Experimental Range; ESA = Ecological Society of America; EST = Ecological Site Type; GPS UTM = Global Positioning System Universal Transverse Mercator; NEON = National Ecological Observatory Network; PNG = Pawnee National Grasslands; USNVC = United States Vegetation Classification.
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Poppenberger, Brigitte, Franz Berthiller, Herwig Bachmann, Doris Lucyshyn, Clemens Peterbauer, Rudolf Mitterbauer, Rainer Schuhmacher, Rudolf Krska, Josef Gl�ssl, and Gerhard Adam. "Heterologous Expression of Arabidopsis UDP-Glucosyltransferases in Saccharomyces cerevisiae for Production of Zearalenone-4-O-Glucoside." Applied and Environmental Microbiology 72, no. 6 (June 2006): 4404–10. http://dx.doi.org/10.1128/aem.02544-05.
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ABSTRACT Zearalenone, a secondary metabolite produced by several plant-pathogenic fungi of the genus Fusarium, has high estrogenic activity in vertebrates. We developed a Saccharomyces cerevisiae bioassay strain that we used to identify plant genes encoding UDP-glucosyltransferases that can convert zearalenone into zearalenone-4-O-glucoside (ZON-4-O-Glc). Attachment of the glucose moiety to zearalenone prevented the interaction of the mycotoxin with the human estrogen receptor. We found that two of six clustered, similar UGT73C genes of Arabidopsis thaliana encode glucosyltransferases that can inactivate zearalenone in the yeast bioassay. The formation of glucose conjugates seems to be an important plant mechanism for coping with zearalenone but may result in significant amounts of “masked” zearalenone in Fusarium-infected plant products. Due to the unavailability of an analytical standard, the ZON-4-O-Glc is not measured in routine analytical procedures, even though it can be converted back to active zearalenone in the digestive tracts of animals. Zearalenone added to yeast transformed with UGT73C6 was converted rapidly and efficiently to ZON-4-O-Glc, suggesting that the cloned UDP-glucosyltransferase could be used to produce reference glucosides of zearalenone and its derivatives.
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Davis, Kathryn, Guili Zhang, Patricia Hodson, Boni Boswell, and James Decker. "A Close Look at the Physical Fitness Levels of Elementary Age Students with Intellectual Disabilities." Sport Science Review 19, no. 3-4 (August 1, 2010): 19–34. http://dx.doi.org/10.2478/v10237-011-0015-x.
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A Close Look at the Physical Fitness Levels of Elementary Age Students with Intellectual DisabilitiesIntroduction: Little is known about the physical fitness levels of school-aged children with intellectual disabilities, when comparing groups of healthy weight and unhealthy weight. Purpose: To compare the fitness levels of healthy weight and unhealthy weight children with intellectual disabilities in three elementary schools in the southeastern United States. Methods: Four fitness measures (PACER, Modified Curl-Ups, Modified Pull-ups, and the Back-Saver Sit-and-Reach) were obtained from 26 youth (10 girls, 16 boys; 10.01 + 1.22). Additionally, fitness levels of students who were overweight/obese were statistically compared with those with healthy weights. Results: A pattern of overall low fitness levels was found in comparison to criterion-referenced standards regarding all of the fitness measures, and students who were overweight/obese performed poorly compared to those with healthy weight. The only statistically significant finding was the comparison of healthy and unhealthy weight groups on the modified pullup. Conclusions: The study suggests a strong need for adaptive physical education and active recess programs that are appropriate for developing the fitness levels of elementary students with intellectual disabilities.
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Coleridge-Smith, Labropoulos, Partsch, Myers, Nicolaides, and Cavezzi. "Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs-UIP consensus document. Part I. Basic principles." Vasa 36, no. 1 (February 1, 2007): 53–61. http://dx.doi.org/10.1024/0301-1526.36.1.53.
Full textAbstract:
Background: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of veins in the lower limb by ultrasound imaging. Methods: The authors invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the experts were made available to all participants via the UIP website. The authors prepared a draft document for discussion at an UIP Chapter meeting held in San Diego, USA in August 2003. Following this meeting a revised manuscript was circulated to all participants and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually all participants agreed the final version of the paper. Results: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination as well as the interpretation of images and measurements obtained. This document suggests a methodology for complete assessment of the superficial and perforating veins of the lower limbs, including recommendations on reporting results and training of personnel involved in these investigations. Conclusions: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography.
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Coleridge-Smith, P., N. Labropoulos, H. Partsch, K. Myers, A. Nicolaides, and A. Cavezzi. "Duplex ultrasound investigation of the veins in chronic venous disease of the lower limbs – UIP Consensus Document. Part I: Basic principles." Phlebology: The Journal of Venous Disease 21, no. 4 (December 1, 2006): 158–67. http://dx.doi.org/10.1258/026835506779115780.
Full textAbstract:
Objectives: Duplex ultrasound investigation has become the reference standard in assessing the morphology and haemodynamics of the lower limb veins. The project described in this paper was an initiative of the Union Internationale de Phlébologie (UIP). The aim was to obtain a consensus of international experts on the methodology to be used for assessment of veins in the lower limb by ultrasound imaging. Design: Consensus conference leading to a consensus document. Methods: The authors invited a group of experts from a wide range of countries to participate in this project. Electronic submissions from the experts were made available to all participants via the UIP website. The authors prepared a draft document for discussion at a UIP Chapter meeting held in San Diego, USA, in August 2003. Following this meeting, a revised manuscript was circulated to all participants, and further comments were received by the authors and included in subsequent versions of the manuscript. Eventually, all participants agreed on a final version of the paper. Results: The experts have made detailed recommendations concerning the methods to be used for duplex ultrasound examination, as well as the interpretation of images and measurements obtained. This document suggests a methodology for complete assessment of the superficial and perforating veins of the lower limbs, including recommendations on reporting results and training of personnel involved in these investigations. Conclusions: The authors and a large group of experts have agreed a methodology for the investigation of the lower limbs venous system by duplex ultrasonography.
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Parmentier, Stefani, Michael Kramer, Swetlana Weller, Ulrich Schuler, Rainer Ordemann, Gabi Rall, Markus Schaich, Martin Bornhäuser, Gerhard Ehninger, and Frank Kroschinsky. "Reevaluation of reference values for bone marrow differential counts in 236 healthy bone marrow donors." Annals of Hematology 99, no. 12 (September 15, 2020): 2723–29. http://dx.doi.org/10.1007/s00277-020-04255-4.
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AbstractDespite the increasing role of molecular markers, differential counts and morphology of hematopoietic cells in the bone marrow (BM) remain essential diagnostic criteria in hematological diseases. However, the respective reference values for BM myelogram commonly used came from small series with limited numbers of healthy individuals. We evaluated the myelograms of 236 healthy individuals who underwent unrelated bone marrow donation. Health check-ups were performed 4 weeks prior to harvest. Samples for this study, taken from the first aspiration, were stained according to the standard Pappenheim method. Three experienced investigators assessed cellularity, megakaryopoiesis, and differential counts independently. The median donor age was 31 (range 18–51) years. Predonation tests did not reveal any relevant morbidity. Thirty-seven out of 42 hypocellular marrow samples were from younger donors up to 39 years. Content of megakaryocytes was normal in 210 specimens (89%). Gender and body mass index had significant impact on hematopoiesis, whereas age had not. The number of erythroblasts was higher (about 32%) and the proportion granulopoiesis slightly lower (about 50%) compared with previous studies. Differential counts showed also some differences with respect to individual maturation stages in these lines. Interrater comparisons showed greater reliability for the assignment of cells to the different hematopoietic cell lines than for single-cell diagnoses. This study largely confirms the results for cell counts in normal human bone marrow available from previous reports and provides some insights into factors that affect individual cell populations. It also reveals substantial variability among even experienced investigators in cytological diagnoses.