General principles and specific problems in bioequivalence study
10.3969/j.issn.1001-6821.2010.01.001
- VernacularTitle:生物等效性研究的一般原则与特殊问题
- Author:
Shui-Qiang WANG
1
;
Jian-Zhong ZHAO
Author Information
1. 国家食品药品监督管理局
- Keywords:
bioequivalence;
general principle;
specific problems
- From:
The Chinese Journal of Clinical Pharmacology
2010;26(1):3-6
- CountryChina
- Language:Chinese
-
Abstract:
This article gives a systemic introduction of general principles and some specific problems in bioequivalence(BE)studies,based on comprehensive review of all the FDA's final copy for Individual Product Bioequivalence Recommendations.Wish to give some suggestions to the design and evaluation of drug BE studies in China.
