研究國內外藥品監(jiān)管機構對咀嚼片仿制藥品種的關鍵質量屬性及生物等效性試驗的要求及相關指導原則，為企業(yè)開展相關品種的一致性評價工作提供借鑒和幫助。從試驗設計、檢測物質選擇、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原則》中相關內容進行詳細分析，以指導我國咀嚼片仿制藥質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）