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1

OLSSON, P. G. "Studien über die Variation des Choleravirus in Bezug auf Biologie und Virulenz." Nordiskt Medicinskt Arkiv 47, no. 10 (April 24, 2009): 1–101. http://dx.doi.org/10.1111/j.0954-6820.1914.tb01550.x.

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2

Pailler, Thierry, Benjamin Warren, and Jean-Noël Labat. "Biologie de la reproduction de Aloe mayottensis (Liliaceae), une espèce endémique de l'île Mayotte (Océan Indien)." Canadian Journal of Botany 80, no. 4 (April 1, 2002): 340–48. http://dx.doi.org/10.1139/b02-019.

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A particularly interesting aspect of the study of organisms in insular environments is plant reproduction and the interaction of plants with their pollinators. Differences in composition between the fauna and flora of continental and island populations, combined with their geographical isolation, have frequently driven rapid evolution in colonizing populations. In particular, floral traits and compatibility systems tend to favour autogamy in response to a paucity of pollinators in the environment. In this context we investigate the origins of the reproductive biology of Aloe mayottensis Berger, a lily endemic to the island of Mayotte. We show that this species is pollinated by the island's endemic sunbird species, and has floral traits and a reproduction system that favour allogamy. Our results show that A. mayottensis is a protandrous and partially self-compatible species. Analysis of stigmatic pollen load shows that stigma received a mean of 56 crossed pollen grains and 62.2 selfed pollen grains per stigma. Study of visitation rates of plants and flowers by the sunbird showed that there is daily variation in the activity of this pollinator, and that males are more active than females.Key words: Aloe mayottensis, floral biology, Lomatophyllum, Nectarinia, bird pollinization, sunbirds, Oceanic islands, Mayotte.
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Ntumba Mabedi, Jean Métis, Victorine Mbadu Zebe, Johan R. Michaux, and Jean-Claude Micha. "Biologie de la reproduction des Marcusenius (M. monteiri, M. stanleyanus, M. schilthuisiae et M. macrolepidotus) du Pool Malebo, fleuve Congo, Kinshasa." International Journal of Biological and Chemical Sciences 16, no. 2 (July 8, 2022): 564–80. http://dx.doi.org/10.4314/ijbcs.v16i2.5.

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Les informations sur la biologie de la reproduction des poissons du genre Marcusenius vivant au pool Malebo, sont peu connues. Pourtant, leur exploitation très importante actuellement se fait sans tenir compte du renouvellement de leurs stocks. Cette étude avait comme objectif de déterminer les stratégies de reproduction de quatre espèces du genre Marcusenius les plus abondantes dans les captures effectuées à l’aide des filets maillants dormants au niveau du pool Malebo. Les quatre espèces de Marcusenius récoltés ont une seule gonade gauche bien développée avec de grands ovocytes presque de même taille, et expulsables en ponte unique. Ces poissons pratiquent une stratégie migratoire dans les sites inondés en début de la saison pluvieuse qui coïncident avec les inondations et une légère variation des paramètres environnementaux de leurs frayères. La fécondité est maximale vers la fin de la saison sèche et début de la saison pluvieuse, entre Août et Septembre. La maturité des gonades chez les femelles commence à partir de Juin et Juillet-Août. Vers fin Septembre et octobre, presque tous les individus adultes de toutes les espèces sont à maturité. A partir de Novembre / Décembre la plupart sont en post ponte.
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4

Hilley, P., C. Li Wai Suen, A. Srinivasan, M. C. Choy, and P. De Cruz. "P379 Variations in disease monitoring between Inflammatory Bowel Disease patients on intravenous and subcutaneous biologic agents." Journal of Crohn's and Colitis 15, Supplement_1 (May 1, 2021): S393. http://dx.doi.org/10.1093/ecco-jcc/jjab076.503.

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Abstract Background The availability of subcutaneous (SC) administration devices of biologics in addition to intravenous (IV) administration has influenced patients’ and clinicians’ preferences towards initiating or transitioning to SC administration particularly during the COVID-19 pandemic. Whilst SC administration improves patient convenience and reduces demands on infusion centres we hypothesised that the reduction in healthcare contact associated with SC therapies may reduce the opportunities available for objective disease assessment. We aimed to compare the uptake of objective assessment of disease activity between patients receiving IV and SC biologic therapy. Methods Patients on maintenance infusion-based or subcutaneous biologic therapy for IBD between 09/2020 and 02/2021 were identified from a prospectively maintained database at an Australian tertiary IBD centre. Patients scheduled for review in IBD clinic for a prescription of maintenance biologic therapy during the follow-up period were included. Clinic records were reviewed to determine whether patients had undergone objective disease assessment including: biochemical investigation (C-Reactive protein) and Faecal Calprotectin (FCP) within the preceding 8 weeks and/or endoscopic/imaging assessment within the preceding 6 months of clinic review. Frequency of objective disease assessment was compared between patients who received IV versus SC maintenance biologic therapy. Results A total of 307 patients were included: IV maintenance n=195 (Infliximab n=135; Vedolizumab n= 60) and SC maintenance n=112 (Adalimumab n=54; Ustekinumab n=54; Golimumab n=4). Patients who received IV biologics were more likely than the SC cohort to have had biochemical assessment in the form of CRP (90% vs 72%, p<0.001) and FCP (54% vs 46%, p=0.16). Patients in the SC biologic cohort were more likely not to have had investigations completed prior to their clinical review (20% versus 4%, p<0.001). There was no difference in the overall rates of complete objective disease assessment (CRP/FCP and endoscopy/imaging) between the IV and SC cohort (28% vs 30% (p=0.74). Conclusion Patients on subcutaneous biologic therapies in our cohort were less likely to have had objective disease monitoring than those receiving intravenous biologics prior to scheduled IBD clinic review. Route of of biologic administration may influence rates of uptake of objective disease activity assessment. Tools that safeguard against the disparity of monitoring uptake, including messaging prompts and patient-centric mobile applications may help standardise the approach to objective disease assessment independent of the route of biologic administration.
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Enos, Clinton W., Hadiza Galadima, Arjun D. Saini, Stacie Bell, Michael Siegel, and Abby S. Van Voorhees. "Predictors of Biologic Use and Satisfaction Among Patients With Psoriasis: An Analysis and Geographic Visualization of the 2016 and 2017 National Psoriasis Foundation Annual Surveys." Journal of Psoriasis and Psoriatic Arthritis 5, no. 3 (July 2020): 100–108. http://dx.doi.org/10.1177/2475530320925553.

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Background: There are an increasing number of biologic therapies approved for the treatment of psoriasis. Previous reports have identified undertreatment as a concern in the United States. Undertreatment has been associated with decreased patient satisfaction and increased morbidity. Objectives: Assess biologic use and satisfaction among respondents to the 2016 and 2017 National Psoriasis Foundation (NPF) Annual Surveys. Methods: Retrospective data analysis of the 2016 and 2017 NPF Annual Survey responses from individuals with psoriasis. ArcGIS Pro software was utilized to generate maps and perform an optimized hot spot analysis of moderate-to-severe psoriasis and biologic use. Results: There were 427 patients with psoriasis involving the skin alone. Biologics were used in <23% of respondents, while nearly 69% reported body surface area (BSA) >3%. Respondents with BSA <3% and 3% to 4% were less likely to be on biologic therapy (odds ratio [OR]: 0.29, 0.11-0.78 and OR: 0.22, 0.09-0.56, respectively). Nonbiologic users were more likely to be very unsatisfied with their treatment compared to those receiving biologic therapy (OR: 5.23, 2.80-9.75). With geographic information systems (GIS), counties with increased moderate-to-severe disease were identified in the southeastern United States. Conclusion: Despite the increasing number of Food and Drug Administration–approved biologic medications, the proportion of respondents on biologic therapy remained small. Treatment with biologics correlated with less residual disease and increased satisfaction. Geographic variation in state legislation as well as state and federal health insurance did not impact biologic use. However, using GIS, we identify a greater burden of moderate-to-severe disease among respondents in the Southeastern United States and a lack of commensurate use of biologics in those areas.
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6

Henderson, I. Craig. "Biologic variations of tumors." Cancer 69, S7 (April 1, 1992): 1888–95. http://dx.doi.org/10.1002/1097-0142(19920401)69:7+<1888::aid-cncr2820691703>3.0.co;2-#.

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7

Galli, Emily, Guodong Liu, Doug Leslie, Joslyn Kirby, and Jeffrey J. Miller. "Prescription Pattern Variability of Biologic Therapies in Treating Psoriasis." Journal of Psoriasis and Psoriatic Arthritis 3, no. 3 (July 2018): 84–87. http://dx.doi.org/10.1177/2475530318781308.

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Background: Medical conditions with high variability in clinical costs and outcomes, such as psoriasis, represent a critical area for health-care value improvement. Thus, the prescription pattern variability of psoriasis biologics merits further study. Objective: The purpose of our study was to determine whether there is variation in psoriasis biologic prescribing patterns. Methods: This study analyzed data from the Truven MarketScan Commercial Claims and Encounters database. Patients with International Classification of Diseases, Ninth Revision psoriasis diagnoses from January 1, 2008, to December 31, 2013, and continuously enrolled for at least 12 months were included. Patient sex, geographic location by census region, and new pharmacy claims for etanercept, adalimumab, and ustekinumab were included. Descriptive and multivariable analyses using logistic regression were performed. Results: Twenty nine thousand seven hundred thirty patients with psoriasis had 36 366 new prescription claims. Statistically significant differences in biologic pharmacy claims existed across US census region and year of claim. The South census region had the most prescriptions (per million population) of each biologic and the greatest increase in new prescriptions for adalimumab and ustekinumab, while the Northeast had the fewest. Etanercept pharmacy claims steadily decreased across all regions over time, while ustekinumab experienced an 8-fold increase. Conclusion: Prescription pattern variability for psoriasis biologics is associated with US census region and year of pharmacy claim.
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Ricós, Carmen, Virtudes Álvarez, Joana Minchinela, Pilar Fernández-Calle, Carmen Perich, Beatriz Boned, Elisabet González, et al. "Biologic Variation Approach to Daily Laboratory." Clinics in Laboratory Medicine 37, no. 1 (March 2017): 47–56. http://dx.doi.org/10.1016/j.cll.2016.09.005.

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9

Moody, J. P. "Biologic Variation of Serum and Salivary Lithium." Therapeutic Drug Monitoring 21, no. 1 (February 1999): 97–101. http://dx.doi.org/10.1097/00007691-199902000-00015.

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10

Sledge, George W. "Innumerable Variations: Combining Biologics." Clinical Breast Cancer 9, no. 1 (February 2009): 7. http://dx.doi.org/10.3816/cbc.2009.n.001.

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11

Jerome, Rebecca N., Jill M. Pulley, Nila A. Sathe, Shanthi Krishnaswami, Alyssa B. Dickerson, Katherine J. Worley, and Consuelo H. Wilkins. "Exploring Biologic Predictors of Response Disparities to Atypical Antipsychotics among Blacks: A Quasi-Systematic Review." Ethnicity & Disease 30, Suppl 1 (April 2, 2020): 229–40. http://dx.doi.org/10.18865/ed.30.s1.229.

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Purpose: Management of schizophrenia among Blacks in the United States is af­fected by persistent disparities. This review explored response to atypical antipsychotics among Blacks compared with other groups to assess systematic variation that may con­tribute to disparities.Methods: We conducted a quasi-systematic review of studies reporting response to atypical antipsychotics among Blacks com­pared with other groups, including effects of genetic variation.Results: Of 48 identified research articles, 29 assessed differences in outcomes without inclusion of genetic variation and 20 ex­plored effects of genetic variation; of note: one article included both types of data. Analysis of the 29 papers with clinical out­comes only suggests that while data on ef­ficacy and risk of movement disorders were heterogeneous, findings indicate increased risk of metabolic effects and neutropenia among Blacks. Of the 20 articles exploring effects of genetic variation, allelic or geno­typic variations involving several genes were associated with altered efficacy or safety among Blacks but not Whites, including risk of decreased response involving variation in DRD4 and DRD1, and improved efficacy as­sociated with variants in DRD2, COMT, and RGS4. Others showed significant improve­ment in treatment response only among Whites, including variation in DTNBP1, DRD4, and GNB3.Conclusions: The current analysis can help tailor management among Blacks using an atypical antipsychotic. Heterogeneity in genetic variation effects and response allele frequency suggests that pharmacogenetics approaches for atypical antipsychotics will need to explicitly incorporate race and eth­nicity.Ethn Dis. 2020;30(Suppl 1):229-240; doi:10.18865/ed.30.S1.229
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12

Miller, J., J. Kirby, D. Leslie, G. Emily, and G. Liu. "202 Prescription variation of biologic therapies for psoriasis." Journal of Investigative Dermatology 136, no. 5 (May 2016): S36. http://dx.doi.org/10.1016/j.jid.2016.02.230.

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13

Bellini, Marilanda Ferreira, Rosana Silistino-Souza, Marileila Varella-Garcia, Maria Tercília Vilela de Azeredo-Oliveira, and Ana Elizabete Silva. "Biologic and Genetics Aspects of Chagas Disease at Endemic Areas." Journal of Tropical Medicine 2012 (2012): 1–11. http://dx.doi.org/10.1155/2012/357948.

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The etiologic agent of Chagas Disease is theTrypanosoma cruzi, transmitted through blood-sucking insect vectors of the Triatominae subfamily, representing one of the most serious public health concerns in Latin America. There are geographic variations in the prevalence of clinical forms and morbidity of Chagas disease, likely due to genetic variation of theT. cruziand the host genetic and environmental features. Increasing evidence has supported that inflammatory cytokines and chemokines are responsible for the generation of the inflammatory infiltrate and tissue damage. Moreover, genetic polymorphisms, protein expression levels, and genomic imbalances are associated with disease progression. This paper discusses these key aspects. Large surveys were carried out in Brazil and served as baseline for definition of the control measures adopted. However, Chagas disease is still active, and aspects such as host-parasite interactions, genetic mechanisms of cellular interaction, genetic variability, and tropism need further investigations in the attempt to eradicate the disease.
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Kroll, Martin H. "Multiple Patient Samples of an Analyte Improve Detection of Changes in Clinical Status." Archives of Pathology & Laboratory Medicine 134, no. 1 (January 1, 2010): 81–89. http://dx.doi.org/10.5858/2008-0652-oar1.1.

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Abstract Context. When comparing results over time, biologic variation must be statistically incorporated into the evaluation of laboratory results to identify a physiologic change. Traditional methods compare the difference in 2 values with the standard deviation (SD) of the biologic variation to indicate whether a “true” physiologic change has occurred. Objective. To develop methodology to reduce the effect of biologic variation on the difference necessary to detect changes in clinical status in the presence of biologic variation. Design. The standard test for change compares the difference between 2 points with the 95% confidence limit, given as . We examined the effect of multiple data pairs on the confidence limit. Results. Increasing the number of data pairs using the formula , where n = number of data pairs, significantly reduces the difference between values necessary to achieve a 95% confidence limit. Conclusions. Evaluating multiple paired sets of patient data rather than a single pair results in a substantial decrease in the difference between values necessary to achieve a given confidence interval, thereby improving the sensitivity of the evaluation. A practice of using multiple patient samples results in enhanced power to detect true changes in patient physiology. Such a testing protocol is warranted when small changes in the analyte precede serious clinical events or when the SD of the biologic variation is large.
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Willett, N., C. G. Heisler, N. Nazer, B. Currie, K. Phalen-Kelly, M. Stewart, and J. Jones. "P338 The effectiveness of a standardised biologic care pathway in the management and treatment of inflammatory bowel disease." Journal of Crohn's and Colitis 14, Supplement_1 (January 2020): S325. http://dx.doi.org/10.1093/ecco-jcc/jjz203.467.

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Abstract Background inflammatory bowel disease (IBD) is a class of chronic immune-mediated diseases. Biologics have revolutionised the treatment of IBD. Existing literature suggests significant variation exists in the use of biologic treatment among physicians, from provider-specific prescribing to completion of the pre-biologic workup. These differences may influence the effectiveness of achieving and maintaining long-term remission. Clinical care pathways can standardise the use of biologics, improve patient outcomes, and increase consistency of care. The aim of the project was to determine whether the use of biologics to treat IBD managed within a standardised biologic care pathway (BCP) is safer and more effective compared with the current standard of care. Methods This was a retrospective, real-world cohort study of a prospectively implemented evidence-based BCP at the Nova Scotia Collaborative IBD (NSCIBD) program between 2015 and 2019. Patient inclusion criteria consisted of an adult with a diagnosis of IBD (including Crohn’s disease, ulcerative colitis, IBD-Unclassified) aged 18 years or older who was managed within the NSCIBD program. Preliminary descriptive analyses of the data are presented. Data collection is ongoing and multivariate analyses will be presented in full at ECCO. Results In total 249 patients were included in the cohort study (111 BCP patients, 138 non-BCP patients). The mean age was 49 years (range of 17–86 years). Sixty-nine per cent (171/249) of patients were diagnosed with CD, 28% (70/249) with UC, and 3% (8/249) with IBD-U. The mean duration of disease was 13 years (range of 0–36 years). Use of combination therapy was similar between the cohorts with 64% of BCP patients (n = 102) and 63% of non-BCP patients (n = 123) on combination therapy. Thirty-eight per cent of the BCP cohort required dosing interval changes vs. 29% in the non-BCP cohort (0.24 fold higher in BCP cohort). Seventy-one per cent of the BCP patients were exposed to TDM vs. 41% of the non-BCP cohort (0.40-fold more TDM in pathway cohort). Although 34% of BCP patients and 38% of non-BCP cohort patients reached clinical remission (n = 103 and 125, respectively), 38% of BCP patients and 21% of non-BCP patients achieved endoscopic remission (0.5-fold lower in the non-BCP cohort), (n = 29 and 53, respectively). Conclusion Preliminary analyses suggest patients managed within a BCP have their biologic management guided more often by the results of TDM and objective biomarkers than those not managed within a BCP. Although clinical remission was observed to be similar between the cohorts, attainment of endoscopic remission was more likely amongst patients managed within the BCP. Additional multivariate analyses will be presented at ECCO with a larger cohort size.
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Willett, N., C. Heisler, N. Nazer, B. Currie, K. Phalen-Kelly, M. Stewart, and J. Jones. "A157 THE EFFECTIVENESS OF A STANDARDIZED BIOLOGIC CARE PATHWAY IN THE MANAGEMENT AND TREATMENT OF INFLAMMATORY BOWEL DISEASE." Journal of the Canadian Association of Gastroenterology 3, Supplement_1 (February 2020): 21–22. http://dx.doi.org/10.1093/jcag/gwz047.156.

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Abstract Background Inflammatory Bowel Disease (IBD) is a class of chronic immune-mediated diseases. Biologics have revolutionized the treatment of IBD. Existing literature suggests significant variation exists in the use of biologic treatment among physicians, from provider-specific prescribing to completion of the pre-biologic workup. These differences may influence the effectiveness of achieving and maintaining long-term remission. Clinical care pathways may serve to standardize the use of biologics in the treatment of IBD leading to improvements in patient outcomes and consistency of care provided from different specialists. Aims To determine if the use of biologics to treat IBD managed within a standardized biologic care pathway (BCP) is safer and more effective compared to the current standard of care. Methods This was a retrospective, real-world cohort study of a prospectively implemented evidence-based BCP at the Nova Scotia Collaborative IBD (NSCIBD) program between 2015 and 2019. Patient inclusion criteria consisted of any adult with a diagnosis of IBD (including Crohn’s Disease, ulcerative colitis, IBD-Unclassified) aged 18 years or older who was managed within the NSCIBD program. Preliminary descriptive analyses of the data are presented. Data collection is ongoing and multivariate analyses will be presented in full at CDDW. Results In total 249 patients were included in the cohort study (111 BCP patients, 138 non-BCP patients). The mean age was 49 years (range of 17–86 years). Sixty-nine percent (171/249) of patients were diagnosed with CD, 28% (70/249) with UC, and 3% (8/249) with IBD-U. The mean duration of disease was 13 years (range of 0–36 years). Use of combination therapy was similar between the cohorts with 64% of BCP patients (n=102) and 63% of non-BCP patients (n=123) on combination therapy. Thirty-eight percent of the BCP cohort required dosing interval changes vs. 29% in the non-BCP cohort (0.24 fold higher in BCP cohort). Seventy-one percent of the BCP patients were exposed to TDM vs. 41% of the non-BCP cohort (0.40-fold more TDM in pathway cohort). Although 34% of BCP patients and 38% of non-BCP cohort patients reached clinical remission (n=103 and 125, respectively), 38% of BCP patients and 21% of non-BCP patients achieved endoscopic remission (0.5-fold lower in the non-BCP cohort), (n=29 and 53, respectively). Conclusions Preliminary analyses suggest patients managed within a BCP have their biologic management guided more often by the results of TDM and objective biomarkers than those not managed within a BCP. Although clinical remission was observed to be similar between the cohorts, attainment of endoscopic remission was more likely amongst patients managed within the BCP. Additional multivariate analyses will be presented at CDDW with a larger cohort size. Funding Agencies None
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Heuser, Michael, and R. Keith Humphries. "Biologic and experimental variation of measured cancer stem cells." Cell Cycle 9, no. 5 (March 2010): 909–12. http://dx.doi.org/10.4161/cc.9.5.10852.

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18

Vasile, Vlad C., Amy K. Saenger, Jean M. Kroning, George G. Klee, and Allan S. Jaffe. "Biologic Variation of a Novel Cardiac Troponin I Assay." Clinical Chemistry 57, no. 7 (July 1, 2011): 1080–81. http://dx.doi.org/10.1373/clinchem.2011.162545.

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19

Goettel, Andrea M., Josh DeClercq, Leena Choi, Thomas B. Graham, and Amy A. Mitchell. "Efficacy and Safety of Abatacept, Adalimumab, and Etanercept in Pediatric Patients With Juvenile Idiopathic Arthritis." Journal of Pediatric Pharmacology and Therapeutics 26, no. 2 (February 15, 2021): 157–62. http://dx.doi.org/10.5863/1551-6776-26.2.157.

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OBJECTIVE The lack of randomized controlled trials comparing biologics for the treatment of juvenile idiopathic arthritis (JIA) has led to wide variation in treatment approaches. The objective of this study is to compare the efficacy and safety of abatacept, adalimumab, and etanercept in JIA patients treated at a tertiary pediatric institution. METHODS This was a single-center, retrospective chart review of patients initiated on abatacept, adalimumab, or etanercept from December 1, 2015, to August 31, 2018, at Monroe Carell Jr. Children's Hospital at Vanderbilt (VCH). The primary outcome was the change in the Physician Global Assessment (PGA) score after 4 to 6 months of biologic therapy. Secondary outcomes included change in laboratory markers of JIA disease activity, change in the number of joints with active disease or limitation of motion, reduction in corticosteroid dose, adverse effects, adherence among patients who have their medications filled at the institution's specialty pharmacy, and reason for discontinuation of therapy. RESULTS A total of 139 patients were included, with a median age of 13 years. Most patients, 80.6%, experienced a reduction in their PGA score after starting biologic therapy. There was not a statistically significant difference among the agents (p = 0.64). Adverse effects were reported in only 26.6% of patients, with the most frequent being injection site reactions or pain (n = 35). Ultimately, 32% of patients discontinued biologic therapy with a lack of efficacy being the most common reason. CONCLUSIONS Abatacept, adalimumab, and etanercept were not significantly different in efficacy and safety for the treatment of JIA at this single institution.
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Wang, Xiu-Mei, Xiangbing Yang, Lian-Sheng Zang, Zheng Wang, Chang-Chun Ruan, and Xian-Jiao Liu. "Effect of geographic variation on biology and cold tolerance of Harmonia axyridis in China." Entomologia Generalis 36, no. 3 (July 1, 2017): 239–50. http://dx.doi.org/10.1127/entomologia/2017/0441.

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Putra, Aldy Darmansyah, Wildan Nurfalah, Emma Hermawati Muhari, and Muchtar Gozali. "Pemanfaatan Limbah Lumpur IPAL Proses Biologi Sebagai Bahan Bakar Alternatif dalam Bentuk Briket." Fluida 15, no. 2 (November 30, 2022): 136–42. http://dx.doi.org/10.35313/fluida.v15i2.4522.

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Industrial WWTP sludge has not been used properly, especially biological process WWTP sludge can be used as an alternative fuel in the form of briquettes. The purpose of this study was to determine potential utilization of biological process WWTP sludge as briquettes, and to determine the effect of adding variations charcoal to the quality of briquettes. The biological process WWTP sludge was obtained from the Trio Food, Cianjur. The dried sludge has a calorific value 2468 cal/g. The research methodology includes material drying, size reduction (250 μm), mixing, molding, and briquette drying. Briquettes are made with variations in the addition of 30%, 40%, 50%, 60%, 70% charcoal. The results of the study showed that the addition of charcoal resulted increase in the water content, fixed carbon, and calorific value of briquettes as well decrease in ash content, and volatile matter. The highest calorific value in the variation of the addition charcoal is 70% at 3819 cal/g, the value still does not meet SNI 1/6235/2000 (standard for wood charcoal briquettes). The biological process WWTP sludge has potential to be used as fuel in the form of briquettes with the addition of coconut shell charcoal and carbonized coal.
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Sander, P. M. "Life history of Tendaguru sauropods as inferred from long bone histology." Fossil Record 2, no. 1 (January 1, 1999): 103–12. http://dx.doi.org/10.1002/mmng.1999.4860020107.

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Abstract. Sauropod dinosaurs present exceptional challenges in understanding their biology because of their exceptional body size. One of these, life history, can be inferred from the histology of their bones. For this purpose, the diverse sauropod assemblage of the Upper Jurassic Tendaguru beds was sampled with a new coring method which provided unprecented access to and insights into sauropod bone histology. Growth series of humeri and femora as well as long growth records from single bones suggest that all four sauropod taxa are characterized by continued growth after sexual maturity but that growth was determinate. Fibrolamellär bone is dominant in the samples, indicating that the bones of the Tendaguru sauropods grew at rates comparable to those of modern large mammals. The growth pattern of these sauropods thus combines typically reptilian traits with typically mammalian traits. In the details of their bone histology, the Tendaguru sauropod taxa show considerable variation which reflects life history. In addition, Barosaurus exhibits probable sexual dimorphism in bone histology. Das Verständnis der Biologie der sauropoden Dinosaurier wird durch ihre enorme Körpergröße außerordentlich erschwert. Allerdings kann ein Aspekt, die Lebensgeschichte, anhand der Histologie ihrer Knochen untersucht werden. Zu diesem Zweck wurde die diverse Sauropoden-Vergesellschaftung der oberjurassischen Tendaguru-Schichten beprobt, und zwar mit einer neuartigen Kernbohrmethode, die einen herausragenden Zugang und Einblick in die Knochenhistologie der Sauropoden ermöglichte. Wachstumsserien von Humeri und Femora sowie umfassende Überlieferungen des Wachstums von Individuen anhand einzelner Knochen machen es wahrscheinlich, daß alle vier Sauropoden-Taxa der Tendaguru-Schichten durch ein auch nach der Geschlechtsreife anhaltendes Wachstum gekennzeichnet waren. Allerdings ging das Wachstum nicht bis zum Tode des Tieres weiter, sondern kam bei einer etwas variablen Maximalgröße zum Stillstand. Fibrolamellärer Knochen ist der vorherrschende Knochentyp in den Proben, was anzeigt, daß die Tendaguru-Sauropoden mit für Säugetieren typische Raten wuchsen. Die Tendaguru-Sauropoden kombinerten also ein für Reptilien typisches Muster des Wachstums, nämlich nach der Geschlechtsreife anhaltendes Wachstum, mit für Säuger typischen Raten des Wachstums. Die verschiedenen Sauropoden-Taxa zeigen erstaunliche Unterschiede in den Details ihrer Knochenhistologie, die Unterschiede in der Lebensgeschichte belegen. Bei Barosaurus scheint außerdem ein Geschlechtsdimorphismus in der Histologie der Langknochen vorzukommen. doi:1002/mmng.1999.4860020107
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Anisdahl, K., S. S. Lirhus, A. W. Medhus, B. Moum, H. O. Melberg, and M. L. Høivik. "P882 Regional differences in biologic and surgical treatment of inflammatory bowel disease in Norway 2011–2019." Journal of Crohn's and Colitis 17, Supplement_1 (January 30, 2023): i999—i1001. http://dx.doi.org/10.1093/ecco-jcc/jjac190.1012.

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Abstract Background We have previously reported regional differences in biologic and surgical treatment for inflammatory bowel disease (IBD) patients diagnosed 2010–2012. In this study, our aim was to explore whether regional differences in the use of biologics and surgery were consistent over time. Methods We performed a nationwide, observational study using linked data from the Norwegian Patient Registry (NPR) and the Norwegian Prescription Database (Nor-PD). Incident cases were defined as ≥2 IBD diagnosis codes in the NPR, or ≥1 IBD diagnosis code in the NPR and ≥2 IBD prescriptions in the NorPD. Kaplan-Meier estimates were used to calculate time from diagnosis to first biologic and/or major surgical event. The log-rank test was used to test for statistical significance. Patients were stratified by health region affiliation (Northern [NR], Central [CR], Western [WR] and South-Eastern [SER]), and grouped as Cohort I (2011–2014) or Cohort II (2015–2019) depending on year of diagnosis. Results We included 7306 patients with Crohn’s disease (CD) and 13688 patients with ulcerative colitis (UC). Results are shown in Figure 1 (CD) and Figure 2 (UC). All cumulative incidences (%) reported below are measured five years after diagnosis. CD patients: In Cohort I, SER had the highest (40%) and CR had the lowest (35%) cumulative incidence of patients starting biologics (p=0.02). In Cohort II, WR had the highest cumulative incidence (53%), and differed significantly from NR and SER (p≤0.04). In Cohort I, there were large regional differences in surgical treatment. NR had lower use of surgery (11%) than all other regions (p≤0.03). In Cohort II, the proportion undergoing surgery had decreased in all regions, except in NR (14%). The use of surgery was lowest in SER (12%), and differed significantly from CR and WR (p≤0.03). UC patients: In Cohort I, SER had the highest cumulative incidence of patients starting biologics (18%), and differed significantly from CR and WR (p≤0.01). In Cohort II, the use of biologics was lower in CR (20%) when compared to all other regions (p≤0.01), while differences between the three other regions were non-significant. CR had the largest proportion of patients undergoing surgery in both Cohort I (8%) and Cohort II (7%), and differed significantly from all other regions in Cohort I (p≤0.05), and SER and WR (p&lt;0.01) in Cohort II. Differences between the three other regions were non-significant. Conclusion The study revealed important, sustained regional differences in the use of both biologics and surgery, especially for UC. Pursuing whether geographical treatment variation impacts outcome will aid in ensuring equal access to best clinical care.
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Ockene, Ira S., Charles E. Matthews, Nader Rifai, Paul M. Ridker, George Reed, and Edward Stanek. "Variability and Classification Accuracy of Serial High-Sensitivity C-Reactive Protein Measurements in Healthy Adults." Clinical Chemistry 47, no. 3 (March 1, 2001): 444–50. http://dx.doi.org/10.1093/clinchem/47.3.444.

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Abstract Background: Increased concentrations of high-sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation, are associated with increased risk for coronary heart disease. Because of its relationship to inflammation, hs-CRP has considerable biologic variation. This study was carried out to characterize CRP variation and to compare it to another risk factor, total serum cholesterol. Methods: One hundred thirteen individuals were scheduled to have five measurements each of hs-CRP and total cholesterol carried out at quarterly intervals over a 1-year period. Variations of hs-CRP and total cholesterol were characterized, and classification accuracy was described and compared for both. Results: The relative variation was comparable for hs-CRP and total cholesterol. When classified by quartile, 63% of first and second hs-CRP measurements were in agreement; for total cholesterol it was 60%. Ninety percent of hs-CRP measurements were within one quartile of each other. This relationship was not altered by the use of log-transformed hs-CRP data. Conclusion: hs-CRP has a degree of measurement stability that is similar to that of total cholesterol.
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Roach, A., I. Scott, G. Macfarlane, G. T. Jones, and A. Macgregor. "OP0284 AN AGENT-BASED SIMULATION OF THE EFFECTS OF VARYING TIME TO TREATMENT WITH BIOLOGICAL AGENTS ON PATIENT HEALTH AND COST IN AXIAL SPONDYLOARTHRITIS USING NATIONAL REGISTER DATA." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 177.1–177. http://dx.doi.org/10.1136/annrheumdis-2020-eular.1507.

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Background:Evaluating the long-term impacts of healthcare policies on patient’s health and treatment costs for people with axial spondyloarthritis (axSpA) is challenging due to its chronic nature, and the variation in individual patient journeys post-diagnosis. Agent-based simulations are a novel approach to interrogating this complexity, and allow the consequences of different policy scenarios on outcomes to be explored.Objectives:Develop and validate an agent-based simulation of the UK axial spondyloarthritis healthcare system, using real-world data.Interrogate the effects of earlier biologic treatment on costs and patient outcomes.Methods:Anonymised data were obtained from the UK National Early Inflammatory Arthritis Audit, and BSR Biologics Register (BSRBR-AS). This provided data on 162 units, and 702 patients with 1,631 patient-years of follow-up. An agent-based model was designed and programmed on the Netlogo platform to simulate patients and units individually over time. New patients were created based on national disease prevalence statistics. Patients’ disease journeys were modelled with a Bath AS Disease Activity Index (BASDAI) score. The model included hospital outpatient attendances, treatment histories, drug costs, and key patient demographics. The baseline simulation was run for two simulated years, repeated 10 times, and assessed against the BSRBR-AS dataset for validation. The model was subsequently used to explore five experimental scenarios in which the time between the date of diagnosis, to first introduction to biologics (d-b) was varied by increasing the number of appointments. The experiment was run 10 times for each parameter setting.Results:In the baseline model in a typical two year run, 13,631 new patients attended 5,167 baseline, and 6,966 follow-up appointments. Of these, 6,324 and 623 were prescribed ≥1NSAID, and biologics, respectively. The validation comparison tests showed a high-level of similarity between simulated output and target datasets. In the target data, d-b was 250 days. In the experimental scenarios, as might be expected, earlier biologic access improved outcomes but at higher-costs (Figure 1; Table 1). Reducing d-b to 150 days doubled the number of patients on biologics at 2 years from 623 to 1,286. It also led to 8% more patients achieving a BASDAI of 0 to 2.5 at 2 years, with 5%, 1%, and 2% less patients achieving 2.5 - 5, 5 to 7.5 and 7.5 to 10 BASDAI, respectively. Reducing d-b to 150 days increased drug costs from £3.2 million to £8.8 million. However, the total number of appointments (a proxy for staff costs) increased proportionality less from 16,000 to 20,000.Table 1.Influence of varying the time between diagnosis to biologic treatment (d-b) on drug-use and staffing costsDiagnosis to Biologic (d-b)Drug Costs Unit (£k)Total AppointmentsNo. patients prescribed NSAIDsNo. patients prescribed Biologics1508,79620,3847,1541,2832205,70218,5926,7969712503,25916,2146,3246212602,05414,7005,9683822651,29713,4115,562233Figure 1.Influence of varying the time between diagnosis to biologic treatment (d-b) on 2 year BASDAI outcomeConclusion:We have successfully developed, and validated an agent-based approach to model the effect of key policy changes on the whole healthcare system, providing output estimates of cost and patient outcomes, based on integrated real-world data. To our knowledge this is the first attempt to explore the patient journey in people with axSpA in this way. The model provides a useful tool for exploring the effects of changing the way healthcare is delivered to patients with this disease. Our experimental analysis lends support to the case for increasing staffing and drug expenditure to achieve current NICE standards of care in AS.Acknowledgments:Financial support National Axial Spondyloarthritis Society (NASS), data access BSR.Disclosure of Interests:Alan Roach Grant/research support from: I was awarded an I-CRP grant from Pfizer for a similar simulation in RA, this was for about £50k and ran from 1/9/15 28/2/17., Ian Scott: None declared, Gary Macfarlane: None declared, Gareth T. Jones Grant/research support from: Pfizer, AbbVie, UCB, Celgene and GSK., Alex MacGregor: None declared
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Otremski, I., M. Katz, G. Livshits, and Z. Cohen. "Biology of aging in an Israeli population. 1. Review of literature and morphological variation analysis." Anthropologischer Anzeiger 51, no. 3 (September 2, 1993): 233–49. http://dx.doi.org/10.1127/anthranz/51/1993/233.

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Fraser, Callum G., Stephen P. Wilkinson, Ronald G. Neville, James D. E. Knox, John F. King, and Ronald S. Macwalter. "Biologic Variation of Common Hematologic Laboratory Quantities in the Elderly." American Journal of Clinical Pathology 92, no. 4 (October 1, 1989): 465–70. http://dx.doi.org/10.1093/ajcp/92.4.465.

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Andersen, Stig, Niels Henrik Bruun, Klaus Michael Pedersen, and Peter Laurberg. "Biologic Variation is Important for Interpretation of Thyroid Function Tests." Thyroid 13, no. 11 (November 2003): 1069–78. http://dx.doi.org/10.1089/105072503770867237.

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Jongerius, Peter H., Jacques van Limbeek, and Jan J. Rotteveel. "Assessment of Salivary Flow Rate: Biologic Variation and Measure Error." Laryngoscope 114, no. 10 (October 2004): 1801–4. http://dx.doi.org/10.1097/00005537-200410000-00023.

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Kuzma, Kori, James Stevenson, Jiachen Liu, Adam Coffman, Obi L. Griffith, Malachi Griffith, Jason Walker, Lawrence Babb, Xuelu Liu, and Alex Wagner. "21. Translating human readable variation descriptions to unique computable variations with the Variation Normalizer." Cancer Genetics 268-269 (November 2022): 7–8. http://dx.doi.org/10.1016/j.cancergen.2022.10.024.

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Cohen, Claudine. "De la biologie au roman : le modèle morphologique et ses variations." Romantisme 138, no. 4 (2007): 47. http://dx.doi.org/10.3917/rom.138.0047.

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de Jong, Daphne, Andreas Rosenwald, Mukesh Chhanabhai, Philippe Gaulard, Wolfram Klapper, Abigail Lee, Birgitta Sander, et al. "Immunohistochemical Prognostic Markers in Diffuse Large B-Cell Lymphoma: Validation of Tissue Microarray As a Prerequisite for Broad Clinical Applications—A Study From the Lunenburg Lymphoma Biomarker Consortium." Journal of Clinical Oncology 25, no. 7 (March 1, 2007): 805–12. http://dx.doi.org/10.1200/jco.2006.09.4490.

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Purpose The results of immunohistochemical class prediction and prognostic stratification of diffuse large B-cell lymphoma (DLBCL) have been remarkably various thus far. Apart from biologic variations, this may be caused by differences in laboratory techniques, scoring definitions, and inter- and intraobserver variations. In this study, an international collaboration of clinical lymphoma research groups from Europe, United States, and Canada concentrated on validation and standardization of immunohistochemistry of the currently potentially interesting prognostic markers in DLBCL. Patients and Methods Sections of a tissue microarray from 36 patients with DLBCL were stained in eight laboratories with antibodies to CD20, CD5, bcl-2, bcl-6, CD10, HLA-DR, MUM1, and MIB-1 according to local methods. The study was performed in two rounds firstly focused on the evaluation of laboratory staining variation and secondly on the scoring variation. Results Different laboratory staining techniques resulted in unexpectedly highly variable results and very poor reproducibility in scoring for almost all markers. No single laboratory stood out as uniformly poor or excellent. With elimination of variation due to staining, high agreement was found for CD20, HLA-DR, and CD10. Poor agreement was found for bcl-6 and Ki-67. Optimization of techniques and uniformly agreed on scoring criteria improved reproducibility. Conclusion This study shows that semiquantitative immunohistochemistry for subclassification of DLBCL is feasible and reproducible, but exhibits varying rates of concordance for different markers. These findings may explain the wide variation of biomarker prognostic impact reported in the literature. Harmonization of techniques and centralized consensus review appears mandatory when using immunohistochemical biomarkers for treatment stratification.
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Fernandes, Laísa, and Patricia Shirley Prado. "Submental Anatomical Variations: The Uniqueness of a Common Variation." Journal of Morphological Sciences 38 (2021): 100–108. http://dx.doi.org/10.51929/jms.38.19.2021.

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Cembrowski, George S., Andrew W. Lyon, Christopher McCudden, Yuelin Qiu, Qian Xu, Junyi Mei, David V. Tran, S. M. Hossein Sadrzadeh, and Mark A. Cervinski. "Transformation of Sequential Hospital and Outpatient Laboratory Data into Between-Day Reference Change Values." Clinical Chemistry 68, no. 4 (February 8, 2022): 595–603. http://dx.doi.org/10.1093/clinchem/hvab271.

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Abstract Background Serial differences between intrapatient consecutive measurements can be transformed into Taylor series of variation vs time with the intersection at time = 0 (y0) equal to the total variation (analytical + biological + preanalytical). With small preanalytical variation, y0, expressed as a percentage of the mean, is equal to the variable component of the reference change value (RCV) calculation: (CVA2 + CVI2)1/2. Methods We determined the between-day RCV of patient data for 17 analytes and compared them to healthy participants’ RCVs. We analyzed 653 consecutive days of Dartmouth-Hitchcock Roche Modular general chemistry data (4.2 million results: 60% inpatient, 40% outpatient). The serial patient values of 17 analytes were transformed into 95% 2-sided RCV (RCVAlternate), and 3 sets of RCVhealthy were calculated from 3 Roche Modular analyzers’ quality control summaries and CVI derived from biological variation (BV) studies using healthy participants. Results The RCVAlternate values are similar to RCVhealthy derived from known components of variation. For sodium, chloride, bicarbonate calcium, magnesium, phosphate, alanine aminotransferase, albumin, and total protein, the RCVs are equivalent. As expected, increased variation was found for glucose, aspartate aminotransferase, creatinine, and potassium. Direct bilirubin and urea demonstrated lower variation. Conclusions Our RCVAlternate values integrate known and unknown components of analytic, biologic, and preanalytic variation, and depict the variations observed by clinical teams that make medical decisions based on the test values. The RCVAlternate values are similar to the RCVhealthy values derived from known components of variation and suggest further studies to better understand the results being generated on actual patients tested in typical laboratory environments.
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Salomo, Salomo, Nova Lestari, and Muhammad Hamdi. "ANALISA PENGARUH GAYA ELEKTROSTATIK PADA SPEKTRUM PENCITRAAN RESONANSI MAGNETIK (MRI) DALAM JARINGAN BIOLOGI." Komunikasi Fisika Indonesia 16, no. 1 (April 30, 2019): 8. http://dx.doi.org/10.31258/jkfi.16.1.8-11.

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A study of magnetic core resonance imaging modeling of biological tissue has been carried out in analyzing the effect of electrostatic forces with computational approach. This analysis aims to look at the effect of electric and magnetic force on the spectrum of breast cancer tissue. Physical parameters were determined using the modeled wave equation with the application of mathematical wolfram software 9. Computational or modeling results obtained 6 variations of the MRI spectrum showing the peak magnitude of the electric and magnetic spectrum changes by varying the resolution and distance. This is evidenced from the maximum resolution range ie the peak of the electric field spectrum at amplitude 25 a.u is at a concentration of 5 ppm. Resolution of spectrum peak medium is at concentration of 3-4 ppm whereas minimum resolution has 4 peak spectrum that is at concentration 1-2 ppm, 2-3ppm, 3-4ppm and 4ppm. the result of MRI spektrum for distance variation resulted in spectrum change, further reduced the distance then the mri spectrum in magnetic and electric field approaching spin 1.
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Cooper, G. R., S. J. Smith, G. L. Myers, E. J. Sampson, and E. Magid. "Estimating and minimizing effects of biologic sources of variation by relative range when measuring the mean of serum lipids and lipoproteins." Clinical Chemistry 40, no. 2 (February 1, 1994): 227–32. http://dx.doi.org/10.1093/clinchem/40.2.227.

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Abstract Biologic intraindividual variation (CVb) is a major source of inaccuracy in current lipid and lipoprotein measurements. Metaanalysis has been used to estimate the average CVb of serum total cholesterol (TC), high-density lipoprotein cholesterol (HDLC), low-density lipoprotein cholesterol (LDLC), and triglyceride (TG). These CVb values are larger than the National Cholesterol Education Program-accepted and -proposed analytic (CVa) goals. Measuring serial specimens reduces the error in determination of the mean concentration used in classification of the patient by cutoff points. We show (a) a convenient technique, based on the relative range, to qualitatively estimate and interpret biologic variation of TC, HDLC, LDLC, and TG, and (b) the number of serial specimens required to meet a total variation goal for measurements of mean lipid and lipoprotein values. A total variation goal has been selected that can be met by two serial specimens for a majority of individuals.
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Freeman, Kathleen P., Randolph M. Baral, Navneet K. Dhand, Søren Saxmose Nielsen, and Asger L. Jensen. "Recommendations for designing and conducting veterinary clinical pathology biologic variation studies." Veterinary Clinical Pathology 46, no. 2 (April 3, 2017): 211–20. http://dx.doi.org/10.1111/vcp.12475.

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Prieto, Jennifer M., Patrick C. Carney, Meredith L. Miller, Mark Rishniw, John F. Randolph, Giosi Farace, Graham Bilbrough, Maha Yerramilli, and Mark E. Peterson. "Biologic variation of symmetric dimethylarginine and creatinine in clinically healthy cats." Veterinary Clinical Pathology 49, no. 3 (July 27, 2020): 401–6. http://dx.doi.org/10.1111/vcp.12884.

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Khankari, Nikhil K., Patrick T. Bradshaw, Lauren E. McCullough, Susan L. Teitelbaum, Susan E. Steck, Brian N. Fink, Xinran Xu, et al. "Genetic variation in multiple biologic pathways, flavonoid intake, and breast cancer." Cancer Causes & Control 25, no. 2 (November 27, 2013): 215–26. http://dx.doi.org/10.1007/s10552-013-0324-8.

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Patterson, K. David. "Biologic variation in health and illness: Race, age and sex differences." Social Science & Medicine 43, no. 8 (October 1996): 1297. http://dx.doi.org/10.1016/0277-9536(96)85827-8.

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Gohil, S. "AB1343-HPR A QUALITATIVE REVIEW ASSESSING THEMATIC OUTCOMES FROM THE PHARMACY-LED ADALIMUMAB BIOSIMILAR SWITCH PLAN ACROSS 3 SPECIALITIES; RHEUMATOLOGY, GASTROENTEROLOGY AND DERMATOLOGY AT UNIVERSITY HOSPITALS OF COVENTRY AND WARWICKSHIRE (UHCW)." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1959.1–1960. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3880.

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Background:The advent of biosimilars has heralded a new era for cost effective biologic prescribing in the NHS. As patents expire for originator biologics, less expensive versions are now widely available as biosimilars. Non-medical switches (for reasons unrelated to a patient’s health) ensure prescribing of best value medicines, and cost savings can be redirected to patient care.1This practice resonates with recommendations from Lord Carter’s 2016 report regarding reducing unwarranted variation in the NHS and adopting cost saving opportunities.2In 2018/19, following loss of patent exclusivity for the expensive adalimumab originator biologic, UHCW worked in accordance with national directives to drive forward one of the largest non-medical biosimilar switches.Objectives:This qualitative review aims to explore the success of the adalimumab biosimilar switch and key themes associated with switch backs/refusals across the Rheumatology (R), Gastroenterology (G) and Dermatology (D) specialities at UHCW.Methods:The switch plan occurred between April-December 2019. 403 patients (R;189, G;176, D; 38) were eligible for switch. Patients were informed of the plan in advance via a patient information leaflet/hospital clinic visits. Switch refusals, withheld treatments and cancellations were documented and patients were advised to contact the hospital pharmacy/clinical teams if they encountered any concerns, adverse effects or lack of efficacy post switch. The clinician would then advise on subsequent management.Results:During April-December 2019, 264/403 patients had been successfully switched (R;122, G;109, D;33). 33/403 patients switched back to the originator biologic (R;22, G;10; D;1). Of the 22 rheumatology switch back patients; 6 patients reported injection site pain and variably headache, fatigue, disease relapse, gastrointestinal (GI) upset, erythema; 10=reported lack of efficacy and variably influenza-type symptoms, relapse in associated psoriasis, difficulty in walking/sleeping, hair loss, excessive perspiration, facial cellulitis, foot drop and GI upset; 1=blepharitis;1=latex allergy before injection; 3=later declined switch; 1=damaged two devices and did not wish to continue biosimilar. Of the 10 gastroenterology switch back patients; 1=injection site pain; 2=lack of efficacy; 1=developed needle phobia; 1=latex allergy before injection; 1=switch detrimental to health; 2=unstable disease; 1=insomnia; 1=pregnancy. The 1 dermatology switch back patient reported injection site pain and bleeding.38/403 patients refused the switch and remained on the originator biologic (R;11, G;27, D;0). 29/403 patients had treatment cancellations and were switched to an alternative biologic (R;17, G;9, D;3). 32/403 patients stopped treatment (R;13, G;19, D;0). Treatment was withheld for 7/403 patients (R;4, G;2, D;1).Conclusion:The UHCW adalimumab biosimilar switch plan succeeded in switching a total of 66% of patients; thus an annual cost saving of £73,020. Injection site pain, most likely due to the biosimilar citrate content, and lack of efficacy according to patient perception and subsequent clinical review, were the most predominant causative themes for switch backs. Gastroenterology patients accounted for 71% (27/38) of the total switch refusals. Additional data regarding patient refusals, identifies future opportunities to improve patient counselling and drive further cost savings.References:[1]Azevedo V, et al. Biosimilars: considerations for clinical practice. Considerations in Medicine. 2017;1(1):13–8[2]Lord Carter of Coles. (2016) Operational productivity and performance in English NHS Acute Hospitals: Unwarranted variations [Online]Acknowledgments:Mark Easter, Chief Pharmacist, Hardeep Bagga, Deputy Chief Pharmacist, UHCW Pharmacy Homecare Team, UHCW Specialist Clinical Teams.Disclosure of Interests:None declared
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Huynh, L., S. Hass, B. E. Sands, M. S. Duh, H. Sipsma, M. Cheng, A. Lax, and A. NAG. "P621 Physician preferences for biologics (originator vs. biosimilar) for the treatment of ulcerative colitis in France, Germany and the UK." Journal of Crohn's and Colitis 14, Supplement_1 (January 2020): S515—S516. http://dx.doi.org/10.1093/ecco-jcc/jjz203.749.

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Abstract Background Although originator biologics are effective therapies for patients with ulcerative colitis (UC), they can be costly and may not be widely available. Therefore, less expensive biosimilars have been developed and approved to treat and manage symptoms. In this new treatment landscape, UC-treatment preferences are unknown. Thus, this interim analysis aimed to characterise physician preferences for biologics for the treatment of UC in France, Germany and the UK. Methods As part of a broader chart review study, treatment preferences were also collected from participating gastroenterologists and general practitioners (GPs) in France, Germany and the UK who had treated patients (≥ 18 years) with moderate-to-severe UC who had received ≥ 1 UC-related biologic any time from 2014 to 25 October 2019. Descriptive statistics were used to describe the sample overall, and by physician speciality and treatment preference. Results Physicians (161 gastroenterologists; 57 GPs) were from different clinical settings in France (39.9%), Germany (28.4%) and the UK (31.7%). Overall, infliximab (33.0%) and adalimumab (32.1%) were selected more often as first treatment options than their biosimilars (17.0% and 9.6%, respectively). Gastroenterologists preferred biosimilars more frequently than GPs did (35.4% vs. 1.8%). More physicians who preferred biosimilars were from France (48.3%) than Germany (17.2%) or the UK (34.5%). In France and the UK, 93.8% of physicians who selected biosimilars worked in hospital settings; in Germany, 50.0% worked in clinics and 50.0% worked in practice settings with statutory and private patients. Physicians who preferred biosimilars treated more patients with UC in the preceding 12 months than those who preferred originators did (mean ± SD: 110.3 ± 113.9 vs. 94.0 ± 93.2). Although most physicians reported efficacy as a reason for biologic preference (93.6%), physicians who preferred originators were more likely to report good tolerability (73.8%) and patient preference (20.6%) and less likely to report affordability or availability (11.9%) than physicians who preferred biosimilars (63.8%, 10.3% and 44.8%, respectively). In patients who failed anti-TNF therapy, vedolizumab was the preferred treatment (78.9%), although this preference differed by speciality (gastroenterologists: 83.2%; GPs: 66.7%). Conclusion Originator biologics for treating patients with moderate-to-severe UC dominate the treatment landscape in Europe, driven primarily by efficacy, tolerability and patient preference. However, variations and differences in preferences by speciality and clinical setting may suggest a need to explore additional treatment options to manage disease symptoms among patients with UC.
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Oğuz, Osman, Hilal Mercan, and F. Sinem Hocaoglu-Emre. "Biological variation of glycated albumin, glucose and albumin in healthy Turkish subjects." Turkish Journal of Biochemistry 46, no. 2 (January 13, 2021): 197–203. http://dx.doi.org/10.1515/tjb-2020-0115.

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Abstract Objectives Biological variation (BV) in laboratory tests can be defined as the variation in analyte concentration over time within and between individuals. Glycated albumin (GA) is a ketoamine which is used in the short-term monitoring of diabetes. The aim of this research was to determine BV of GA, glucose, and albumin under a well-designed and standardized protocol. Methods Blood samples were collected weekly from 21 healthy subjects (10 males, 11 females) for four consecutive weeks. Samples were analyzed using enzymatic methods in duplicate. After subjected to outlier and normality tests, variables as the within-subject biologic coefficient of variation (CVI) and between-subject biologic coefficient of variation (CVG), the index of individuality (II), and reference change value (RCV) were calculated. Results Analytical coefficient of variation (CVA) was 3.5, 1.78, and 2.9%, for GA, glucose and albumin, respectively. The estimates for CVI and CVG: GA: 4.1%, 6.3%; glucose: 3.8%, 4.8%; albumin: 3.5%, 4%. RCVs and IIs were: 15%, 0.60; 12%, 0.79; 13%, 0.9 for GA, glucose and albumin, respectively. Conclusions The BV data of GA derived from this study might be applied to understand routine test results better and establish the quality standards for the analyte.
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SCRIVO, ROSSANA, ILARIA SAUZULLO, FABIO MENGONI, ROBERTA PRIORI, MARIATERESA COPPOLA, GIANCARLO IAIANI, MANUELA DI FRANCO, VINCENZO VULLO, CLAUDIO MARIA MASTROIANNI, and GUIDO VALESINI. "Mycobacterial Interferon-γ Release Variations During Longterm Treatment with Tumor Necrosis Factor Blockers: Lack of Correlation with Clinical Outcome." Journal of Rheumatology 40, no. 2 (December 1, 2012): 157–65. http://dx.doi.org/10.3899/jrheum.120688.

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Objective.To assess the performance of serial QuantiFeron-TB Gold In-Tube (QFT-GIT) tests in patients with rheumatic diseases during longterm systemic treatment with biologic therapy, evaluating conversions and reversions in relation to the clinical outcome.Methods.We conducted a prospective study on patients awaiting biologic agents. At baseline, they had chest radiographs, QFT-GIT tests, and tuberculin skin tests (TST); QFT-GIT was repeated at 3, 6, 12, and 18 months after onset of biologic therapy. In patients with no evidence of latent tuberculosis infection (LTBI) at baseline, TST was repeated at 12 months of biologic treatment.Results.Among patients (n = 102; women 65.7%; median age 47 yrs, range 20–82), 14 (13.7%) were considered as having LTBI because of a minimum of 1 abnormal screening test. The agreement between QFT-GIT and TST was 88% (κ = 0.14). During biologic treatment, both patients with (n = 14) and those without (n = 88) evidence of LTBI at baseline showed conversions and reversions in QFT-GIT results at different timepoints. These fluctuations were not paralleled by significant clinical changes. The TST repeated at 12 months in patients with no evidence of LTBI at baseline continued to be negative. The median baseline interferon-γ (IFN-γ) concentration was not significantly different from that observed at each subsequent timepoint.Conclusion.Dynamic changes occur with serial IFN-γ release assay testing in patients treated with biologic therapy that do not correlate with clinical outcome. A careful and integrated evaluation of the patient, including clinical information, should guide the treatment decision. This study was underpowered for definite conclusions and further studies are needed to determine the significance of these findings.
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Capo, Alessandra, Marta Di Nicola, Matteo Auriemma, Stefano Piaserico, Chiara Cuccurullo, Francesca Santilli, Giovanni Davi, and Paolo Amerio. "Mean platelet volume variation after biologic therapy in psoriasis and psoriatic arthritis." European Journal of Dermatology 24, no. 1 (January 2014): 133–35. http://dx.doi.org/10.1684/ejd.2014.2269.

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Fraser, Callum G. "Clinically Useful Limits (CUL) Criteria Best Based on Within-Subject Biologic Variation." American Journal of Clinical Pathology 92, no. 2 (August 1, 1989): 256. http://dx.doi.org/10.1093/ajcp/92.2.256a.

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Braga, Federica, Dominika Szőke, Cristina Valente, and Mauro Panteghini. "Biologic variation of copper, ceruloplasmin and copper/ceruloplasmin ratio (Cu:Cp) in serum." Clinica Chimica Acta 415 (January 2013): 295–96. http://dx.doi.org/10.1016/j.cca.2012.11.007.

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48

Van Ness, Brian G., John C. Crowley, Christine Ramos, Suzanne M. Grindle, Antje Hoering, Jeff Haessler, Susanna Jacobus, et al. "SNP Associations with Event Free Survival in Myeloma from Two Phase III Clinical Trials Using the Bank On A Cure Chip." Blood 108, no. 11 (November 16, 2006): 131. http://dx.doi.org/10.1182/blood.v108.11.131.131.

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Abstract While there are certain common clinical features in myeloma, the disease shows significant heterogeneity with regard to disease progression, and responses to therapy, affecting both survival and toxicities. Heritable variations in a wide variety of genes and pathways affecting cellular functions and drug responses likely impact patient outcomes. In the Bank On A Cure (BOAC) program we have developed a custom chip that assesses 3,404 SNPs representing variations in cellular functions and pathways that may be involved in myeloma progression and response. The chip has gone through rigorous quality controls checks for high call rates, accuracy, and reproducibility that will be presented. Using the BOAC chip, we have conducted studies to look for SNPs that may identify biologic variations that are associated with good or poor response across a variety of treatments. In this study we looked for SNPs that may distinguish short term and long term survivors in two phase III clinical trials: ECOG E9486 and intergroup trial S9321. E9487 patients were treated with VBMCP followed by randomization to no further treatment, IFN-alpha, or cylcophosphamide; and, although there was variation in survival, no significant differences in survival were noted among the 3 arms of the trial. Patients included in this SNP study from S9321 received VAD induction followed by randomization to VBMCP or high dose melphalan + TBI. SNP profiles were obtained for patients with less than 1 year EFS (n=20 in E9487; n=50 in S9321) and patients showing greater than 3 years EFS (n=32 in E9486; n=41 in S9321). Statistical approaches were performed to identify single and groups of SNPs that best discriminated the survival groups. Previous studies have suggested genetic variations in drug metabolism genes, p-glycoprotein transport, and DNA repair genes may influence survival outcomes. Our results show significant survival associations of genetic variations in genes within these functional categories (eg. GST, XRCC, ABCB, and CYP genes). Although genetic variations were found that were uniquely associated with each clinical trial, several of these genetic variations show survival associations that increase in significance when the two trials were examined as a conglomerate data set. Grouping genetic variations through common pathway approaches using gene set enrichment analysis, as well as clustering or partitioning algorithms, further improve the value of the SNPs as potential prognostic markers of survival outcomes. These results and statistical approaches will be presented, and represent steps toward identifying patient variations in biologic mechanisms important in predicting therapeutic outcomes.
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Saret, CJ, MJ Cangelosi, JD Chambers, JT Cohen, and PJ Neumann. "Geographic Variation In Local Medicare Coverage For Part B Biologics." Value in Health 16, no. 3 (May 2013): A10. http://dx.doi.org/10.1016/j.jval.2013.03.062.

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Bortfeld, Thomas, and Harald Paganetti. "The biologic relevance of daily dose variations in adaptive treatment planning." International Journal of Radiation Oncology*Biology*Physics 65, no. 3 (July 2006): 899–906. http://dx.doi.org/10.1016/j.ijrobp.2006.02.036.

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