研究國內(nèi)外藥品監(jiān)管機(jī)構(gòu)對咀嚼片仿制藥品種的關(guān)鍵質(zhì)量屬性及生物等效性試驗的要求及相關(guān)指導(dǎo)原則，為企業(yè)開展相關(guān)品種的一致性評價工作提供借鑒和幫助。從試驗設(shè)計、檢測物質(zhì)選擇、受試者選擇、給藥條件、豁免條件、體外溶出試驗等多個方面對FDA發(fā)布的《單項品種的生物等效性指導(dǎo)原則》中相關(guān)內(nèi)容進(jìn)行詳細(xì)分析，以指導(dǎo)我國咀嚼片仿制藥質(zhì)量與療效的一致性評價。

To study regulatory considerations including critical quality attributes and bioequivalence guidelines of generic chewable tablets from different countries, in order provide reference and help for the consistency evaluation of related varieties. "Bioequivalence Recommendations for Specific Products" issued by FDA were analyzed from multiple aspects, including study design, selection of detectable substance and e subjects, dosage, conditions of to administration and exemption, dissolution tests, etc. These guidelines may have important inspiration of the consistency evaluation on quality and effect of generic chewable tablets in China.

國家重大新藥創(chuàng)制科技重大專項資助項目（2017ZX09101001）