Consideration on the post approval change evaluation of in vitro dissolution profile for solid oral dosage forms of chemical drugs
HU Tao
SHENG Yan
QIAN Jing
LIANG Jin-feng
Abstract：Post approval change is an important part of drug life cycle management,which has potential impact on drug quality.As an important index for evaluating post approval change of oral solid preparations,dissolution curve reveals the quality consistency between the reference listed drug and the generic preparation.Therefore,it has been paid more and more attention by regulatory authorities and drug developers.In this paper,the technical requirements for dissolution curves of oral solid preparations in post approval changes are compared and analyzed,and some risk factors for evaluating dissolution curves of oral solid preparations are analyzed and summarized,in order to help marketing authorization holder to do research on post approval changes of ordinary oral solid preparations.
Keywords：post approval changesdissolution curveoral solid preparationsreference listed druggeneric preparations
Publication Date：2024-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 2239-2245 )