根據(jù)目前國際上對(duì)生物樣品定量分析的相關(guān)指導(dǎo)原則，建議《中國藥典》修訂和擴(kuò)充現(xiàn)有的的指導(dǎo)原則，以適應(yīng)新藥開發(fā)和仿制藥開發(fā)的需求。內(nèi)容包括：指導(dǎo)原則適用范圍，生物分析方法確證，試驗(yàn)樣品分析，配體結(jié)合分析，試驗(yàn)報(bào)告，以及生物分析相關(guān)定義。其中，對(duì)基質(zhì)效應(yīng)、已測(cè)樣品再分析、穩(wěn)定性考察等列出了詳細(xì)的要求。

This is the draft version for the Guidance on Bioanalysis in China Pharmacopoeia, 2015 Edition. The recommendations are based on the current international guidelines and for adepting the requirements to the development of new drugs and generic drugs. It is composed of scope of the guidance, method validation, analysis of study samples, incurred samples reanalysis, ligand binding assays, reports, and definitions. Detailed requirements for matrix effect, incurred samples reanalysis, and stability investigation are introduced.