Innovations in Food and Chemical Safety, Agency for Science, Technology, and Research, Singapore, Singapore.
Skin Research Institute of Singapore, Agency for Science, Technology, and Research, Singapore, Singapore.
Drug Metab Rev. 2021 Aug;53(3):434-458. doi: 10.1080/03602532.2021.1959606. Epub 2021 Aug 23.
A reliable, rapid, and effective bioanalytical method is essential for the determination of the pharmacokinetic, pharmacodynamic, and toxicokinetic parameters that inform the safety and efficacy profile of investigational drugs. The overall goal of bioanalytical method development is to elucidate the procedure and operating conditions under which a method can sufficiently extract, qualify, and/or quantify the analyte(s) of interest and/or their metabolites for the intended purpose. Given the difference in the physicochemical properties of small and large molecule drugs, different strategies need to be adopted for the development of an effective and efficient bioanalytical method. Herein, we provide an overview of different sample preparation strategies, analytical platforms, as well as procedures for achieving high throughput for bioanalysis of small and large molecule drugs.
对于确定可提供药物安全性和疗效概况的药代动力学、药效动力学和毒代动力学参数而言，可靠、快速和有效的生物分析方法至关重要。生物分析方法开发的总体目标是阐明程序和操作条件，在此条件下，可以充分提取、定性和/或定量感兴趣的分析物（及其代谢物）及其用于预期目的的代谢物。鉴于小分子药物和大分子药物在物理化学性质上存在差异，因此需要采用不同的策略来开发有效的生物分析方法。本文概述了用于小分子药物和大分子药物生物分析的不同样品制备策略、分析平台以及实现高通量的方法。
