生物样品中化学药物定量分析方法验证的进展与解读

建立可靠的和可重现的定量分析方法是进行药代动力学、毒代动力学、生物等效性、生物利用度等研究的关键之一。为了保证分析方法可靠，必须进行方法验证。本文通过分析总结国内外指导原则、文献、会议报告等，介绍了生物分析领域的若干重要会议和指导原则颁布实施过程，综述了小分子化学药物生物分析方法验证应当包括的内容和具体验证方法，总结了我国与美国和欧盟的指导原则在某些细节规定上的差异，以及将来的全球一致化进程。

The reliable and reproducible quantitative bioanalysis method is the backbone of pharmacokinetic,toxicokinetic,bioequivalence and bioavailability studies.It is necessary to validate bioanalytical methods to ensure the reliability of the analytical methods.By retrieving guidelines,publications and meeting presentations from different countries,several important conferences in the bioanalysis field,and the process of issue and implementation of guiding principles were outlined,fundamental parameters and detailed protocols of bioanalytical method validation for micromolecule medicines were described,the differences between the US,EMA and Chinese regulations were summarized,and the global harmonization of bioanalytical guidance in the future was discussed.

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