參考國際上的相關(guān)指導(dǎo)原則，對《中國藥典》2015年版藥物制劑生物利用度和生物等效性指導(dǎo)原則提出了修改草案。包括前言，常釋制劑生物等效性試驗的設(shè)計、實施和評價，調(diào)釋制劑和透皮吸收制劑的生物等效性試驗，試驗報告，與生物等效性試驗相關(guān)的體外溶出度檢查，對不同劑型的生物等效性要求，以及基于生物藥劑學(xué)分類系統(tǒng)的生物豁免。與現(xiàn)行藥典指導(dǎo)原則相比，把生物樣品定量分析方法的內(nèi)容分離出去，對試驗藥品的規(guī)格、參比制劑選取、測試原形藥物還是代謝物、高變異性藥品生物等效性等提供了新的建議，強調(diào)溶出度實驗的意義，并引入了生物試驗豁免的相關(guān)內(nèi)容。

This is the draft version for the Guidance on the Bioavailability and Bioequivalence Study of Drug Products in China Pharmacopoeia, 2015 Edition. It includes the introduction, design, conduct and evaluation of bioequivalence studies for immediate release formulations with systemic action, study report, bioequivalence study requirements for different dosage forms, and biowaiver based on biopharmaceutics classification system (BCS). In comparison to the current guidance, the bioanalytical method is separated as a discrete guidance, and new recommendations are provided for the selection of reference product, strength to be investigated, parent compound or metabolites, and bioequivalence of highly variable drugs. The importance of in vitro dissolution tests is highlighted and the BCS-based biowaiver is introduced.