Investigating the Discriminatory Power of BCS-Biowaiver in Vitro Methodology to Detect Bioavailability Differences between Immediate Release Products Containing a Class I Drug-Reference-Cited by-同舟云学术

Investigating the Discriminatory Power of BCS-Biowaiver in Vitro Methodology to Detect Bioavailability Differences between Immediate Release Products Containing a Class I Drug

Published:2015-08-26 Issue:9 Volume:12 Page:3167-3174
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Colón-Useche Sarin¹²³,González-Álvarez Isabel¹,Mangas-Sanjuan Victor¹,González-Álvarez Marta¹,Pastoriza Pilar²,Molina-Martínez Irene²,Bermejo Marival¹,García-Arieta Alfredo⁴

Affiliation:

1. Engineering: Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 Alicante, Spain

2. Pharmacokinetics and Pharmaceutical Technology, Complutense University of Madrid, 28040 Madrid, Spain

3. Analysis and Control Department, University of Los Andes, Mérida, Venezuela

4. Service on Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products, 28022 Madrid, Spain

Funder

Ministerio de Ciencia e Innovaci?n

Consejo de Desarrollo Cient?fico Human?stico, Tecnol?gico y de las Artes, Universidad de Los Andes

Direcci?n de Asuntos Profesorales, Universidad de Los Andes

Ministerio de Educacion, Cultura y Deporte

European Commission

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.5b00076

Reference31 articles.

1. E. M. A.Committee for Medicinal Products for Human Use (CHMP).Guideline on the Investigation of Bioequivalence20-1- 2010.

2. US FDA; US Departamentof Health and Human Services; Center for Drug Evaluation and Research.Guidance for Industry: Bioavailability and Bioequivalence Studiesfor Orally Administered Drug Products-General Considerations. (2003.

3. Lamouche, S.; Leonard, H.; Shink, E.; Tanguay, M.The biopharmaceutical classification system: Can it help predict bioequivalence outcome? A CRO retrospective analysis, 2008. Accessed August 24, 2015, athttp://abstracts.aaps.org/SecureView/AAPSJournal/radcyl1pizj.pdf.

4. Acceptability and characteristics of 124 human bioequivalence studies with active substances classified according to the Biopharmaceutic Classification System

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