Opinions and suggestions of bioequivalent studies on modified new drugs
10.13699/j.cnki.1001-6821.2016.14.027
- VernacularTitle:改良型新药生物等效性研究的思考及建议
- Author:
Zi-Ning WANG
1
;
Xia ZHAO
;
Yi-Min CUI
Author Information
1. 北京大学第一医院药剂科
- Keywords:
modified new drug;
bioequivalence;
clinical equivalence;
proposal
- From:
The Chinese Journal of Clinical Pharmacology
2016;32(14):1341-1344
- CountryChina
- Language:Chinese
-
Abstract:
Following the reformation of the new drug classification , it be-comes a new issue of how to confirm the bioequivalence for category 2 new drugs, i.e., the Modified New Products.There are occasional cases when the modified ones are bio -( pharmacokinetic ) but not clinical -equivalent compare to their reference products , and vice versa.If it comes up with different results , clinical-equivalence is considered to be more powerful compare to bio -equivalent result , and the regulatory approval will be done mainly based on clinical rather than bio -equivalent result alone.The present paper provides decision -making cases done by different authorities on products for which the bio -equivalent results are negative while they are proved to be clinically equivalent .These cases provide new ways of thinking for local pharmaceutical companies and can also be used as references for China Food and Drug Administration ( CFDA) in reviewing the same kind of products .
