1.2. Основы концепции биоэквивалентности

Видео, состоящее из двух частей, посвящено основам концепции биоэквивалентности как способа экстраполяции данных по безопасности и эффективности одного лекарственного препарата на другой на основании данных о сопоставимой биодоступности (часть 2/2). Использованная литература Oral drug absorption : prediction and assessment. Jennifer B. Dressman, Christos Reppas (Eds). — 2nd ed. Informa Healthcare USA, Inc., New York. 2010 Biopharmaceutics Applications in Drug Development. Rajesh Krishna, Lawrence Yu (Eds.). Springer Science+Business Media, LLC. 2008 Hauschke, Dieter. Bioequivalence studies in drug development : methods and applications / Dieter Hauschke, Volker Steinijans, Iris Pigeot. p. ; cm. John Wiley & Sons Ltd. 2007 Shein-Chung Chow, Jen-pei Liu. Design and Analysis of Bioavailability and Bioequivalence Studies, 3d Ed. Taylor & Francis Group, LLC. 2009 Pharmaceutical Dissolution Testing. Jennifer Dressman, Johannes Krämer (Eds.). Taylor & Francis Group, LLC. 2005 Method Validation in Pharmaceutical Analysis. A Guide to Best Practice. Joachim Ermer, John H.McB. Miller (Eds.). WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim. 2005 Arthur J. Atkinson Jr. et al. Principles of Clinical Pharmacology. — 3nd ed. Academic Press, 2013 Julious, Steven A. Sample sizes for clinical trials / Steven A. Julious. p. ; cm. Taylor & Francis Group, LLC. 2010 Stephen S. Senn. Cross-over Trials in Clinical Research, 2nd Edition. John Wiley & Sons, Ltd. 2002 EMA. Investigation of bioequivalence (2010) EMA. Modified-release oral and transdermal dosage forms: Section II (1999) EMA. Pharmacokinetic and clinical evaluation of modified-release dosage forms (2013) EMA. Bioanalytical method validation (2012) EMA. Pharmacokinetic studies in man (1987) EMA. Process validation (2014) US FDA. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations (2003) US FDA. Dissolution Testing of Immediate Release Solid Oral Dosage Forms (1997) US FDA. Food-Effect Bioavailability and Fed Bioequivalence Studies (2002) US FDA. Statistical Approaches to Establishing Bioequivalence (2001) US FDA. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations (1997) US FDA. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (2000) US FDA. Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (2013) US FDA. Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations (2013) US FDA. Bioanalytical Method Validation (2001, 2013) US FDA. Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (1995) US FDA. SUPAC-MR: Modified Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation