摘要
按照国家卫生部新药临床指导原则中有关《药物制剂人体生物利用度试验指导原则》，重点介绍控／缓释制剂的动力学特性和人体生物利用度研究要求，提出单剂量交叉试验、多剂量稳态试验以及体内外试验的相关性研究方法。同时介绍申报要点、生物等效性评价、统计分析、资料整理，为研制和申报新药提供参考。
Based on “Experimental Guidelines on Human Bioavailability Study of Pharmaceutical Preparations”contained in “Clinical Guidelines of New Drugs ”issued by MPH of China,the pharmacokinetic characteristics and general requirements for the bioavailability study of controlled(sustained)-release preparations are introduced here.A single-dose crossover test and a multiple-dose steady-state test and correlation between in vitro and in vivo tests are described.The key points for register application,bioequiva-lent evaluation,statistical analysis,and presentation of test results are also provided.It would be a useful reference for new drug development and its register application.
出处
《中国新药杂志》
CAS
CSCD
1996年第3期167-174,共8页
Chinese Journal of New Drugs
关键词
控释制剂
缓释制剂
药代动力学
生物利用度
Controlled-release preparation
Sustained-release preparation
Phar-macokinetics
Bioavailability
Bioequivalent
Application principles
