Exploring the Feasibility of Biowaiver Extension of BCS Class III Drugs with Site-Specific Absorption Using Gastrointestinal Simulation Technology

Authors: Sun L, Sun J, He Z
Publication: Eur J Drug Metab Pharmacokinet
Keywords: biological models, computer simulation, gastrointestinal tract (GIT), humans, intestinal absorption, permeability

Background and Objectives

The US Food and Drug Administration, World Health Organization and European Medicines Agency have allowed biowaiver for some BCS class III drugs, but shortened the requisite dissolution time of BCS class III drugs from 30 to 15 min, considering their site-specific absorption and others risk. The objective of this study was to assess the effects of site-specific absorption, low absorbed fraction (F a) and gastric emptying rate on the biowaiver extension of BCS class III drugs.