Aoyagi N
National Institute of Health Sciences, Tokyo, Japan.
Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):28-31. doi: 10.1007/BF03190053.
The guideline of bioequivalence tests for generic drugs in our country was recently revised (1), and guidelines for formulation change and different strengths were published in February 2000. This paper describes those guidelines briefly.
我国近期修订了仿制药生物等效性试验指南(1)，并于2000年2月发布了剂型变更和不同规格的指南。本文简要介绍这些指南。
