The analysis of unconventional research projects and common problems in the in vitro consistency evaluation of oral solid generic drugs
10.16438/j.0513-4870.2021-0123
- VernacularTitle:口服固体仿制药体外一致性评价中的非常规研究及常见问题解析
- Author:
Na ZHAO
;
Jing SHI
- Publication Type:Research Article
- Keywords:
oral solid generic drug;
italic>in vitro consistency evaluation;
unconventional research project;
similarity evaluation of dissolution curve;
bioequivalence waiver
- From:
Acta Pharmaceutica Sinica
2021;56(6):1739-1744
- CountryChina
- Language:Chinese
-
Abstract:
Based on the "requirements on the submitted documents for consistency evaluation of generic oral solid dosage forms of chemical drugs" and relevant guidance, this article summarized and formulated the decision tree of in vitro consistency evaluation of oral solid generic drugs, discussed the differences and common problems of in vitro evaluation research projects under different conditions, selective analyzed the technical requirements and concern problems of unconventional research projects, and proposed corresponding recommendations for concern problems, in order to provide more references for the follow-up study on consistency evaluation of oral solid generic drugs.
