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[摘要]
美国制药学会(AAPS)联合美国食品药品监督管理局(FDA)分别于1990年、2000年以及2006年召开了3届生物分析方法研讨班,在前两届研讨班的基础上,FDA于2001年出台了一份正式的生物分析方法指导原则。回顾和阐述生物分析方法在近20年取得的发展和进步,为生物分析方法具体应用到动物或人体的生物利用度、生物等效性以及药代动力学研究提供指导和建议。
[Key word]
[Abstract]
The First, Second and Third AAPS/FDA Bioanalytical Workshop were held in 1990, 2000, and 2006, respectively. In the meantime, FDA issued a formal guideline of bioanalytical method validation in 2001.The purpose of this paper is to represent the progress and developments in analytical methodologies over the last 2 decades. The paper is also intended to provide guiding principles for validation of bioanalytical methods employed in support of bioavailability, bioequivalence, and pharmacokinetic studies in man and in animals.
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