To see the other types of publications on this topic, follow the link: Biopharmaceutics.

Journal articles on the topic 'Biopharmaceutics'

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the top 50 journal articles for your research on the topic 'Biopharmaceutics.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.

1

Cvijic, Sandra, Svetlana Ibric, and Jelena Parojcic. "Integrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application." Chemical Industry 74, no. 6 (2020): 389–97. http://dx.doi.org/10.2298/hemind210104002c.

Full text
Abstract:
The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships between drug product quality attributes (in vitro data) and its clinical performance (in vivo data). In the present paper, contemporary biopharmaceutics toolkit including in vivo predictive dissolution testing, Biopharmaceutics Classification System, physiologically based pharmacokinetic and biopharmaceutics modeling and simulation, in vitro-in vivo correlation and biowaiver, are reviewed with regards to relevant general principles and applicability. The recently introduced innovative strategy for patient-centric drug development using an integrated systems approach grounded in fundamental biopharmaceutics concepts, clinical insights and therapeutic drug delivery targets, described as Biopharmaceutics Risk Assessment Roadmap (BioRAM) is also presented. Further development in the field will benefit from joint efforts and exchange of knowledge and experiences between pharmaceutical industry and regulatory authorities for the common goal to accelerate development of effective and safe drug products designed in accordance with patients? needs and expectations.
APA, Harvard, Vancouver, ISO, and other styles
2

Huang, Ziyi, Xinyu Li, Yakun Sun, Zekai Song, Lei Wang, Lenian Yu, Zhenning Wang, and Jie Liu. "Enhancing the Electrochemical Properties and Processing Techniques of Carbon Nanotubes for Bio pharmacological Applications: A Research Perspective." Highlights in Science, Engineering and Technology 58 (July 12, 2023): 297–303. http://dx.doi.org/10.54097/hset.v58i.10111.

Full text
Abstract:
Compared with other biopharmaceutical technologies, carbon nanotubes not only have unique structure, but also have strong electrochemical properties, which occupy an important position in the fields of chemistry, physics, biopharmaceutics and materials science, and have played an active role in promoting the development of biopharmaceutics and chemical industry in China. Carbon nanotubes (CNTs) are mainly used in the field of biopharmacology for the determination of small biological molecules and drug molecules, the determination of dopamine and thrombin, the determination of high concentrations of ascorbic acid, and the detection of drug formulations. Although carbon nanotubes (CNTs) have many advantages in the field of biopharmaceutics, there are certain limitations that limit the scope of application of carbon tubes, which are mainly the following: one is the high cost of the carbon nanotube material itself and the high technical difficulty of its preparation; the other is that the smooth surface of the material is not conducive to the loading of other particles; finally, although the carbon nanotubes are modified with different groups after treatment, the structure of the material itself is damaged. Finally, although carbon nanotubes are modified with different groups after treatment, their own material structure is destroyed, which reduces their conduction performance. Although the above defects can affect the performance of carbon nanotubes, they can be solved by optimizing the structure of carbon nanotubes, enhancing the plastic mechanical properties of carbon nanotubes and corrosion resistance, in order to give full play to the role of carbon nanotubes in the field of biopharmaceuticals. In this regard, the author briefly analyzes the electrochemical properties of carbon nanotubes in biopharmacology and the application of treatment methods based on relevant literature and work experience, hoping to provide reference value for related scholars and researchers.
APA, Harvard, Vancouver, ISO, and other styles
3

Silva, Daniela Amaral, M. Kenneth Cor, Afaseneh Lavasanifar, Neal M. Davies, and Raimar Löbenberg. "Using GastroPlus to teach complex biopharmaceutical concepts." Pharmacy Education 22, no. 1 (May 28, 2022): 336–47. http://dx.doi.org/10.46542/pe.2022.221.336347.

Full text
Abstract:
Context: In response to the COVID-19 pandemic, many educational adjustments had to be made to move in-person teaching to online classrooms. This report showcases the use of the software GastroPlus in an undergraduate-level pharmacy course. Programme description: This course aimed for the students to learn how to perform a mechanistically based simulation to predict the oral absorption pattern, pharmacokinetics, and biopharmaceutics properties of compounds in humans. The computer simulation offered the opportunity to teach concepts about bioavailability providing all kinds of experience with major biopharmaceutic determinants that affect systemic drug exposure. Evaluation: The advantage of this approach was seen by the enhanced performance on the biopharmaceutics questions on the final exam compared with the previous year where the laboratory was not implemented: An increase from 2019 (where no laboratory was implemented) through 2021 incorrect scores from 52, 76 to 75%, respectively. Conclusion: There is great benefit in using computer programs and simulations as a technique to enhance active learning and to educate pharmacy students in salient aspects of biopharmaceutics.
APA, Harvard, Vancouver, ISO, and other styles
4

Chavda, HV, CN Patel, and IS Anand. "Biopharmaceutics classification system." Systematic Reviews in Pharmacy 1, no. 1 (2010): 62. http://dx.doi.org/10.4103/0975-8453.59514.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Idkaidek, Nasir M. "Interplay of biopharmaceutics, biopharmaceutics drug disposition and salivary excretion classification systems." Saudi Pharmaceutical Journal 22, no. 1 (January 2014): 79–81. http://dx.doi.org/10.1016/j.jsps.2013.02.002.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Srinivas, NuggehallyR. "Biopharmaceutics, formulations and exposure." Asian Journal of Pharmaceutics 4, no. 1 (2010): 1. http://dx.doi.org/10.4103/0973-8398.63972.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

O'MULLANE, J. E., P. ARTURSSON, and E. TOMLINSON. "Biopharmaceutics of Microparticulate Drug Carriers." Annals of the New York Academy of Sciences 507, no. 1 Biological Ap (December 1987): 120–40. http://dx.doi.org/10.1111/j.1749-6632.1987.tb45796.x.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Ivanov, V. T., and V. I. Deigin. "Evolution of Peptide Drug Biopharmaceutics." Russian Journal of Bioorganic Chemistry 49, no. 3 (June 2023): 422–34. http://dx.doi.org/10.1134/s1068162023030123.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Malviya, Smriti. "Biopharmaceutics: Drug absorption and bioavailability." Pharma Innovation 8, no. 1 (January 1, 2019): 809–12. http://dx.doi.org/10.22271/tpi.2019.v8.i1m.25484.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Martinez, M. "Applying the Biopharmaceutics Classification System to veterinary pharmaceutical products Part I: Biopharmaceutics and formulation considerations." Advanced Drug Delivery Reviews 54, no. 6 (October 4, 2002): 805–24. http://dx.doi.org/10.1016/s0169-409x(02)00070-4.

Full text
APA, Harvard, Vancouver, ISO, and other styles
11

Charalabidis, Aggelos, Maria Sfouni, Christel Bergström, and Panos Macheras. "The Biopharmaceutics Classification System (BCS) and the Biopharmaceutics Drug Disposition Classification System (BDDCS): Beyond guidelines." International Journal of Pharmaceutics 566 (July 2019): 264–81. http://dx.doi.org/10.1016/j.ijpharm.2019.05.041.

Full text
APA, Harvard, Vancouver, ISO, and other styles
12

de Castro, Lara Maria Lopes, Jacqueline de Souza, Tamires Guedes Caldeira, Bruna de Carvalho Mapa, Anna Flávia Matos Soares, Bruna Gomes Pegorelli, Carolina Carvalho Della Croce, and Neila Márcia Silva Barcellos. "The Evaluation of Valsartan Biopharmaceutics Properties." Current Drug Research Reviews 12, no. 1 (June 19, 2020): 52–62. http://dx.doi.org/10.2174/2589977511666191210151120.

Full text
Abstract:
Background: Solubility, intestinal permeability and dissolution are the main factors that govern the rate and extent of drugs absorption and are directly related to bioavailability. Biopharmaceutics Classification System (BCS) is an important tool which uses in vitro results for comparison with bioavailability in vivo (biowaiver). Valsartan is widely used in the treatment of hypertension and shows different BCS classification in the literature (BCS class II or III). Objective: This work proposes the study of valsartan biopharmaceutics properties and its BCS classification. Methods: High Performance Liquid Chromatography (HPLC) method was developed and validated to quantify the drug in buffers pH 1.2, 4.5 and 6.8 respectively. Valsartan solubility was determined in these three different media using shake flask method and intrinsic dissolution rate. Evaluation of dissolution profile from coated tablets was conducted. Results: The low solubility (pH 1.2 and 4.5) and high solubility (pH 6.8) were observed for both solubility methods. Permeability data reported from the literature showed that valsartan is a low permeability drug. Valsartan presented the rapid release profile only in pH 6.8. Conclusion: We defined that valsartan is a class IV drug, in disagreement with what has been published so far. It is important to emphasize that the conditions considered here are indicated to define the biopharmaceutics classification by regulatory agencies.
APA, Harvard, Vancouver, ISO, and other styles
13

S., Doktorovova, Gokce E., Ozyazici M., and Souto B. "Lipid Matrix Nanoparticles: Pharmacokinetics and Biopharmaceutics." Current Nanoscience 5, no. 3 (August 1, 2009): 358–71. http://dx.doi.org/10.2174/157341309788921516.

Full text
APA, Harvard, Vancouver, ISO, and other styles
14

Awofisayo, Sunday, Augustine Okhamafe, Ehijie Enato, and Matthew Arhewoh. "Crystallography and Biopharmaceutics of Some Antimalarials." British Journal of Pharmaceutical Research 5, no. 6 (January 10, 2015): 379–91. http://dx.doi.org/10.9734/bjpr/2015/15832.

Full text
APA, Harvard, Vancouver, ISO, and other styles
15

Reddy, B. Basanta Kumar, and A. Karunakar. "Biopharmaceutics Classification System: A Regulatory Approach." Dissolution Technologies 18, no. 1 (2011): 31–37. http://dx.doi.org/10.14227/dt180111p31.

Full text
APA, Harvard, Vancouver, ISO, and other styles
16

Panchagnula, R. "Biopharmaceutics and pharmacokinetics in drug research." International Journal of Pharmaceutics 201, no. 2 (May 25, 2000): 131–50. http://dx.doi.org/10.1016/s0378-5173(00)00344-6.

Full text
APA, Harvard, Vancouver, ISO, and other styles
17

Stolk, L. M. L., and A. H. Siddiqui. "Biopharmaceutics, pharmacokinetics and pharmacology of psoralens." General Pharmacology: The Vascular System 19, no. 5 (January 1988): 649–53. http://dx.doi.org/10.1016/0306-3623(88)90122-x.

Full text
APA, Harvard, Vancouver, ISO, and other styles
18

Aiache, Jean-Marc. "An overview about Biopharmaceutics in Europe." European Journal of Drug Metabolism and Pharmacokinetics 30, no. 1-2 (March 2005): 19–27. http://dx.doi.org/10.1007/bf03226404.

Full text
APA, Harvard, Vancouver, ISO, and other styles
19

Touchette, Mark A., and David J. Edwards. "Book Review: Biopharmaceutics and Clinical Pharmacokinetics." DICP 25, no. 1 (January 1991): 104–5. http://dx.doi.org/10.1177/106002809102500127.

Full text
APA, Harvard, Vancouver, ISO, and other styles
20

Woodcock, Barry G. "Biopharmaceutics and clinical pharmacokinetics 3rd edn." Trends in Pharmacological Sciences 6 (January 1985): 183–84. http://dx.doi.org/10.1016/0165-6147(85)90083-5.

Full text
APA, Harvard, Vancouver, ISO, and other styles
21

Baweja, Raman. "Applied Biopharmaceutics and Pharmacokinetics, 2nd ed." Journal of Pharmaceutical Sciences 74, no. 10 (July 1985): 1140. http://dx.doi.org/10.1002/jps.2600741039.

Full text
APA, Harvard, Vancouver, ISO, and other styles
22

Bauer, Larry A. "Biopharmaceutics and clinical pharmacokinetics, 4th edition." Journal of Pharmaceutical Sciences 76, no. 2 (February 1987): 186. http://dx.doi.org/10.1002/jps.2600760225.

Full text
APA, Harvard, Vancouver, ISO, and other styles
23

Neville, Mary E., Lawrence T. Boni, Laura E. Pflug, Mircea C. Popescu, and Richard J. Robb. "BIOPHARMACEUTICS OF LIPOSOMAL INTERLEUKIN 2, ONCOLIPIN." Cytokine 12, no. 11 (November 2000): 1691–701. http://dx.doi.org/10.1006/cyto.2000.0769.

Full text
APA, Harvard, Vancouver, ISO, and other styles
24

Langer, Robert. "Chemical materials and their regulation of the movement of molecules." Quarterly Reviews of Biophysics 48, no. 4 (July 16, 2015): 424–28. http://dx.doi.org/10.1017/s0033583515000165.

Full text
Abstract:
AbstractMaterials chemistry has been fundamental to the enormous field that encompasses the delivery of molecules both to desired sites and/or at desired rates and durations. The field encompasses the delivery of molecules including fertilizers, pesticides, herbicides, food ingredients, fragrances and biopharmaceuticals. A personal perspective is provided on our early work in this field that has enabled the controlled release of ionic substances and macromolecules. Also discussed are new paradigms in creating biomaterials for human use, the non-invasive delivery of molecules through the skin and lungs, the development of intelligent delivery systems and extensions to nanomedicine. With the advent of potentially newer biopharmaceutics such as siRNA, mRNA and gene editing approaches and their use being limited by delivery, future research in this field may be more critical than ever before.
APA, Harvard, Vancouver, ISO, and other styles
25

McAllister, Mark, Talia Flanagan, Karin Boon, Xavier Pepin, Christophe Tistaert, Masoud Jamei, Andreas Abend, Evangelos Kotzagiorgis, and Claire Mackie. "Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives." Pharmaceutics 12, no. 1 (December 23, 2019): 19. http://dx.doi.org/10.3390/pharmaceutics12010019.

Full text
Abstract:
A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that were involved in product development shared their experiences with in vitro dissolution and in silico modeling approaches to establish clinically relevant dissolution specifications. The regulators shared their perspectives on the acceptability of these different strategies for the development of acceptable specifications. The meeting also reviewed several collaborative initiatives that were relevant to regulatory biopharmaceutics. Following the scientific presentations, a roundtable session provided an opportunity for delegates to discuss the information that was shared during the presentations, debate key questions, and propose strategies to make progress in this critical area of regulatory biopharmaceutics. It was evident from the presentations and subsequent discussions that progress continues to be made with approaches to establish robust CRDS. Further dialogue between industry and regulatory agencies greatly assisted future developments and key areas for focused discussions on CRDS were identified.
APA, Harvard, Vancouver, ISO, and other styles
26

Jusko, William J. "Book Review: Biopharmaceutics and Pharmacokinetics—Volume 1 Biopharmaceutics, Volume II, Experimental Pharmacokinetics, and Volume III Clinical Pharmacokinetics." Drug Intelligence & Clinical Pharmacy 20, no. 2 (February 1986): 158. http://dx.doi.org/10.1177/106002808602000219.

Full text
APA, Harvard, Vancouver, ISO, and other styles
27

Benet, Leslie Z. "The Role of BCS (Biopharmaceutics Classification System) and BDDCS (Biopharmaceutics Drug Disposition Classification System) in Drug Development." Journal of Pharmaceutical Sciences 102, no. 1 (January 2013): 34–42. http://dx.doi.org/10.1002/jps.23359.

Full text
APA, Harvard, Vancouver, ISO, and other styles
28

Budha, Nageshwar, Richard Lee, and Bernd Meibohm. "Biopharmaceutics, Pharmacokinetics and Pharmacodynamics of Antituberculosis Drugs." Current Medicinal Chemistry 15, no. 8 (April 1, 2008): 809–25. http://dx.doi.org/10.2174/092986708783955509.

Full text
APA, Harvard, Vancouver, ISO, and other styles
29

Andryushchenko, I. V., and H. H. Valiullin. "PRIORITIES OF IMPORT SUBSTITUTION IN SEZ: BIOPHARMACEUTICS." Business Strategies, no. 8 (October 29, 2015): 1. http://dx.doi.org/10.17747/2311-7184-2015-8-1.

Full text
APA, Harvard, Vancouver, ISO, and other styles
30

Liang, Xing-Jie, Chunying Chen, Yuliang Zhao, Lee Jia, and Paul Wang. "Biopharmaceutics and Therapeutic Potential of Engineered Nanomaterials." Current Drug Metabolism 9, no. 8 (October 1, 2008): 697–709. http://dx.doi.org/10.2174/138920008786049230.

Full text
APA, Harvard, Vancouver, ISO, and other styles
31

FISET, PIERRE, CAROL COHANE, SUSAN BROWNE, STEPHEN C. BRAND, STEVEN L. SHAFER, and Ferne B. Sevarino. "Biopharmaceutics of a New Transdermal Fentanyl Device." Survey of Anesthesiology 40, no. 6 (December 1996): 382. http://dx.doi.org/10.1097/00132586-199612000-00053.

Full text
APA, Harvard, Vancouver, ISO, and other styles
32

ZHANG, Xin, Yang SUN, Ying CHENG, Wei-Liang YE, Bang-Le ZHANG, Qi-Bing MEI, and Si-Yuan ZHOU. "Biopharmaceutics classification evaluation for paris saponin VII." Chinese Journal of Natural Medicines 18, no. 9 (September 2020): 714–20. http://dx.doi.org/10.1016/s1875-5364(20)60010-3.

Full text
APA, Harvard, Vancouver, ISO, and other styles
33

Le Corre, Pascal, Gilles Dollo, François Chevanne, and Roger Le Verge. "Biopharmaceutics and metabolism of yohimbine in humans." European Journal of Pharmaceutical Sciences 9, no. 1 (October 1999): 79–84. http://dx.doi.org/10.1016/s0928-0987(99)00046-9.

Full text
APA, Harvard, Vancouver, ISO, and other styles
34

Zuidema, J., and H. J. A. Wynne. "Data-reduction problems in biopharmaceutics and pharmacokinetics." Pharmaceutisch Weekblad Scientific Edition 11, no. 3 (October 1989): 76–82. http://dx.doi.org/10.1007/bf02110253.

Full text
APA, Harvard, Vancouver, ISO, and other styles
35

Rothe, Achim, Ralf J. Hosse, and And Barbara E. Power. "In vitro display technologies reveal novel biopharmaceutics." FASEB Journal 20, no. 10 (August 2006): 1599–610. http://dx.doi.org/10.1096/fj.05-5650rev.

Full text
APA, Harvard, Vancouver, ISO, and other styles
36

Cook, Jack A., Barbara M. Davit, and James E. Polli. "Impact of Biopharmaceutics Classification System-Based Biowaivers†." Molecular Pharmaceutics 7, no. 5 (October 4, 2010): 1539–44. http://dx.doi.org/10.1021/mp1001747.

Full text
APA, Harvard, Vancouver, ISO, and other styles
37

Fiset, Pierre, Carol Cohane, Susan Browne, Stephen C. Brand, and Steven L. Shafer. "Biopharmaceutics of a New Transdermal Fentanyl Device." Anesthesiology 83, no. 3 (September 1, 1995): 459–69. http://dx.doi.org/10.1097/00000542-199509000-00004.

Full text
Abstract:
Background Compared with conventional routes of delivering potent analgesics to postoperative patients, transdermal administration of fentanyl offers the advantages of simplicity and noninvasive delivery. The only available form of transdermal fentanyl, the Duragesic system, has been implicated in preventable patient deaths when used for postoperative analgesia and is contraindicated in the management of postoperative pain. We examined the biopharmaceutics of a new transdermal fentanyl device developed by Cygnus and intended for use as a postoperative analgesic to see whether the new formulation offers pharmacokinetic advantages that might permit safe use in postoperative patients. Methods We studied 15 consenting male adult surgical patients. Patients received 650 or 750 micrograms intravenous fentanyl as part of the induction of anesthesia. Plasma fentanyl concentrations were measured over the following 24-h period. On the first postoperative day, 24 h after the intravenous dose of fentanyl, a transdermal fentanyl device was placed on the upper torso of the patient for 24 h and then removed. Plasma fentanyl concentrations were measured for 72 h after application of the transdermal fentanyl device. From the concentration versus time profile for the 24 h after intravenous fentanyl administration we determined each patient's clearance and unit disposition function by moment analysis and constrained numeric deconvolution, respectively. From the concentration versus time profile for the 72 h after application of the transdermal device we determined the amount of fentanyl absorbed and the rate of absorption, again by moment analysis and constrained numeric deconvolution. The residual fentanyl in the transdermal fentanyl device was measured, permitting calculation of the absolute bioavailability of transdermally administered fentanyl. Results Of the 14 subjects who received transdermal fentanyl, 3 had clinically significant fentanyl toxicity, mandating early removal of the device. The range during the plateau from 12 to 24 h in subjects still wearing the device was 0.34-6.75 ng/ml, a 20-fold range in concentration. In subjects wearing the device for 24 h, the terminal half-life of fentanyl after removal of the device was 16 h. The bioavailability of transdermally administered fentanyl was 63 +/- 35% coefficient of variation. The rate of fentanyl absorption from 12-24 h ranged from 10 to 230 micrograms/h in subjects still wearing the device. In two subjects, the rate within the first 6 h briefly exceeded 300 micrograms/h. Both of these subjects demonstrated fentanyl toxicity, requiring early removal of the device. Conclusions The Cygnus transdermal fentanyl device shows great variability in the rate of fentanyl absorption, resulting in highly variable plasma fentanyl concentrations. Some persons may rapidly absorb fentanyl from the device in the first few hours after application, leading to fentanyl toxicity. The variability in effect of the Cygnus transdermal fentanyl device is appreciably greater than that reported for the currently available Duragesic transdermal fentanyl device, which is contraindicated for postoperative analgesia.
APA, Harvard, Vancouver, ISO, and other styles
38

Wang, Wei. "Protein aggregation and its inhibition in biopharmaceutics." International Journal of Pharmaceutics 289, no. 1-2 (January 2005): 1–30. http://dx.doi.org/10.1016/j.ijpharm.2004.11.014.

Full text
APA, Harvard, Vancouver, ISO, and other styles
39

Jung, Ha Neul, and Jin-Seok Choi. "Development and Evaluation of Febuxostat Solid Dispersion through Ternary System." Yakhak Hoeji 68, no. 2 (March 30, 2024): 105–11. http://dx.doi.org/10.17480/psk.2024.68.2.105.

Full text
Abstract:
Febuxostat is classified as a biopharmaceutical with low solubility in aqueous solution and high intestinal permeability (Biopharmaceutics Classification System [BCS] Class II drug). The solubility of a drug has the characteristic of increasing as pH increases. This study aims to improve the dissolution of febuxostat with Neusilin® US2 and Gelucire®50/13 by a solvent evaporation method. The optimal formulation (solid dispersion, SD1) is developed as a solid dispersion of febuxostat : Gelucire®50/13 : US2®= 1:2:4 (w/w), with a final weight of 280 mg. The dissolution of SD1 in distilled water is 72.0±2.8%, which is 1.67-fold higher than that of the commercial product, Feburic Tab® (43.2±1.8%). The SD1 formulation is believed to have improved dissolution due to changes in physicochemical properties (thermal, interaction, and crystallinity). In conclusion, through the solid dispersion manufacturing method, febuxostat is changed from a crystalline form to an amorphous form in SD1 formulation, and the improved dissolution of febuxostat formulation is developed.
APA, Harvard, Vancouver, ISO, and other styles
40

Miranda, Claudia, Alexis Aceituno, Mirna Fernández, Gustavo Mendes, Yanina Rodríguez, Verónica Llauró, and Miguel Ángel Cabrera-Pérez. "ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries." Pharmaceutics 13, no. 3 (March 10, 2021): 363. http://dx.doi.org/10.3390/pharmaceutics13030363.

Full text
Abstract:
The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.
APA, Harvard, Vancouver, ISO, and other styles
41

Dahan, Arik, and Isabel González-Álvarez. "Regional Intestinal Drug Absorption: Biopharmaceutics and Drug Formulation." Pharmaceutics 13, no. 2 (February 17, 2021): 272. http://dx.doi.org/10.3390/pharmaceutics13020272.

Full text
Abstract:
The gastrointestinal tract (GIT) can be broadly divided into several regions: the stomach, the small intestine (which is subdivided to duodenum, jejunum, and ileum), and the colon. The conditions and environment in each of these segments, and even within the segment, are dependent on many factors, e.g., the surrounding pH, fluid composition, transporters expression, metabolic enzymes activity, tight junction resistance, different morphology along the GIT, variable intestinal mucosal cell differentiation, changes in drug concentration (in cases of carrier-mediated transport), thickness and types of mucus, and resident microflora. Each of these variables, alone or in combination with others, can fundamentally alter the solubility/dissolution, the intestinal permeability, and the overall absorption of various drugs. This is the underlying mechanistic basis of regional-dependent intestinal drug absorption, which has led to many attempts to deliver drugs to specific regions throughout the GIT, aiming to optimize drug absorption, bioavailability, pharmacokinetics, and/or pharmacodynamics. In this Editorial we provide an overview of the Special Issue "Regional Intestinal Drug Absorption: Biopharmaceutics and Drug Formulation". The objective of this Special Issue is to highlight the current progress and to provide an overview of the latest developments in the field of regional-dependent intestinal drug absorption and delivery, as well as pointing out the unmet needs of the field.
APA, Harvard, Vancouver, ISO, and other styles
42

Youn, Yu Seok, and Beom-Jin Lee. "Conference Report: Pharmaceutical Technology, Biopharmaceutics and Drug Delivery." Therapeutic Delivery 2, no. 3 (March 2011): 297–99. http://dx.doi.org/10.4155/tde.11.2.

Full text
APA, Harvard, Vancouver, ISO, and other styles
43

Verma, Hitesh, and Rajeev Garg. "Biopharmaceutics classification and pharmacokinetics study of magnesium orotate." Magnesium Research 32, no. 4 (November 2019): 132–42. http://dx.doi.org/10.1684/mrh.2020.0462.

Full text
APA, Harvard, Vancouver, ISO, and other styles
44

Overdiek, H. W. P. M., and F. W. H. M. Merkus. "THE METABOLISM AND BIOPHARMACEUTICS OF SPIRONOLACTONE IN MAN." Drug Metabolism and Drug Interactions 5, no. 4 (January 1987): 273–302. http://dx.doi.org/10.1515/dmdi.1987.5.4.273.

Full text
APA, Harvard, Vancouver, ISO, and other styles
45

Burton, Michael E. "New Publication: Biopharmaceutics and Clinical Pharmacokinetics, 4th Edition." Journal of Pharmacy Technology 7, no. 6 (November 1991): 217. http://dx.doi.org/10.1177/875512259100700604.

Full text
APA, Harvard, Vancouver, ISO, and other styles
46

Brown, Cynthia K. "Biopharmaceutics Classification System: Interview with Prof. Gordon Amidon." Dissolution Technologies 5, no. 4 (1998): 13–14. http://dx.doi.org/10.14227/dt050498p13.

Full text
APA, Harvard, Vancouver, ISO, and other styles
47

Cook, Jack A., and Howard N. Bockbrader. "An Industrial Implementation of the Biopharmaceutics Classification System." Dissolution Technologies 9, no. 2 (2002): 6–8. http://dx.doi.org/10.14227/dt090202p6.

Full text
APA, Harvard, Vancouver, ISO, and other styles
48

Lennernäs, H., B. Abrahamsson, E. M. Persson, and L. Knutson. "Oral drug absorption and the Biopharmaceutics Classification System." Journal of Drug Delivery Science and Technology 17, no. 4 (2007): 237–44. http://dx.doi.org/10.1016/s1773-2247(07)50090-0.

Full text
APA, Harvard, Vancouver, ISO, and other styles
49

Zhang, Jianjun, Dapeng Liu, Yanting Huang, Yuan Gao, and Shuai Qian. "Biopharmaceutics classification and intestinal absorption study of apigenin." International Journal of Pharmaceutics 436, no. 1-2 (October 2012): 311–17. http://dx.doi.org/10.1016/j.ijpharm.2012.07.002.

Full text
APA, Harvard, Vancouver, ISO, and other styles
50

Lennernäs, Hans. "Regional intestinal drug permeation: Biopharmaceutics and drug development." European Journal of Pharmaceutical Sciences 57 (June 2014): 333–41. http://dx.doi.org/10.1016/j.ejps.2013.08.025.

Full text
APA, Harvard, Vancouver, ISO, and other styles
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography