日本生物利用度和生物等效性指南。
Japanese guidance on bioavailability and bioequivalence.
作者信息
Aoyagi N
机构信息
National Institute of Health Sciences, Tokyo, Japan.
出版信息
Eur J Drug Metab Pharmacokinet. 2000 Jan-Mar;25(1):28-31. doi: 10.1007/BF03190053.
PMID:11032086
Abstract
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.
摘要
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。
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本文引用的文献
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Bioavailability of sugar-coated tablets of thiamine disulfide in humans. I. Effect of gastric acidity and in vivo-in vitro correlation.二硫胺素糖衣片在人体中的生物利用度。I. 胃酸的影响及体内-体外相关性
Chem Pharm Bull (Tokyo). 1986 Jan;34(1):281-91. doi: 10.1248/cpb.34.281.
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