Discussion on Polymorphs in the Consistency Assessment of Generic Drugs
10.3870/j.issn.1004-0781.2017.06.001
- VernacularTitle:仿制药一致性评价相关药物晶型的问题分析
- Author:
Guanhua DU
;
Yang LYU
- Keywords:
Generic drugs;
Consistency assessment;
Polymorphs
- From:
Herald of Medicine
2017;36(6):593-596
- CountryChina
- Language:Chinese
-
Abstract:
This study discussed problems in consistency assessment of generic drugs and analyzed effect of polymorphs on drug quality and its influence on consistency of curative efficiency.Relationship between evaluation method of polymorphs and curative efficiency was investigated.It showed that establishment of curative efficiency related evaluation indicators was necessary and improvment of techniques was important.Drug quality criteria should be added with requirement of curative efficiency control.Related information based on polymorphs could be provided for technical research in consistency assessment.
