Towards Virtual Bioequivalence Studies for Oral Dosage Forms Containing Poorly Water-Soluble Drugs: A Physiologically Based Biopharmaceutics Modeling (PBBM) Approach
Author:
Funder
Astellas Pharma
Publisher
Elsevier BV
Subject
Pharmaceutical Science
Reference36 articles.
1. Guidance for Industry: Immediate Release Solid Oral Dosage Forms: Scale-Up and Postapproval Changes,1995
2. Biopharmaceutics Classification System-Based Biowaivers (M9),2019
3. A comparative analysis of biopharmaceutics classification system and biopharmaceutics drug disposition classification system: a cross-sectional survey with 500 bioequivalence studies;Cristofoletti;J Pharm Sci,2013
4. Analysis of intra- and intersubject variability in oral drug absorption in human bioequivalence studies of 113 generic products;Sugihara;Mol Pharm,2015
5. Usage of in vitro metabolism data for drug-drug interaction in physiologically based pharmacokinetic (PBPK) analyses submissions to the U.S. Food and Drug Administration;Lee;J Clin Pharmacol,2021
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