Analysis of common problems in chemical manufacturing and control dossiers and research of supplemental applications for post-approval chemical drugs
WU Xiao-fei
LIU Dan-xing
ZHANG Xin
WANG Hong-liang
BAI Yu
Abstract：In order to improve the quality and efficiency of the evaluation of supplemental applications for post-approval chemical drugs,this article summarized the common problems in chemical manufacturing and control dossiers of supplemental applications,and put forward same relevant suggestions on the preparation of application dossiers of supplemental applications.At the same time,combined with the specific cases encountered during the review of supplemental applications,the common problems in variation research were summarized from the aspects of the rationality of variation,studies of formulation and manufacturing process,and studies of quality,etc.,so as to provide references for relevant researchers to improve the quality of application dossiers and variation research.
Keywords：supplemental applicationsapplication dossiersvariation researchcommon problems
Publication Date：2024-08-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1647-1652 )