Discussion on new methods and their applications for evaluation of generic drugs
CHEN Si
HUANG Zhe
Abstract：Traditional evaluation methods for generic drugs mainly include in vitro quality evaluation,non-clinical safety evaluation,and in vivo bioequivalence(BE)studies.It is highly difficult to evaluate bioequivalence between complex generic drugs and their references,and new generic evaluation methods need to be introduced to replace the difficult,long testing cycle,and costly human BE tests.This article introduced new methods for generic drugs evaluating,including establis-hing virtual bioequivalence by physiologically-based pharmacokinetic(PBPK)models and using in vitro studies to replace BE experiments,to provide ideas and references for of generic drugs evaluation in China.
Keywords：Generic drugsEvaluation methodPKPB modelIn vitro studiesBE exemption
Publication Date：2023-12-28
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 1047-1050 )