Analysis the policies about the procedures and contents on generic drug quality equivalence assessment
ZHANG Liying
LIU Xuliang
ZHANG Libao
Abstract：In order to develop the generic drug quality equivalence assessment,China Food and Drug Administration (CFDA) introduce a lot of policies and technical guidelines.Based on the induction summary,this review discussed the procedures and contents of generic drug quality equivalence assessment to provide reference for evaluation of the consistency.
Keywords：Generic drugConsistency evaluationIn vitro dissolution curves
Publication Date：2017-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 305-307 )