富馬酸喹硫平片主要用于治療精神分裂癥、雙相情感障礙的躁狂發(fā)作，屬精神類疾病臨床常用藥物。結合美國及中國該品種生物等效性試驗指導原則要求，通過對近年來中國富馬酸喹硫平片開展生物等效性試驗結果進行總結、分析，并對本品種生物等效性試驗提出審評的一般要求如下：建議采用兩制劑、兩周期、兩序列交叉設計，開展單次給藥的空腹及餐后人體生物等效性研究，也可采用部分重復或完全重復交叉試驗設計；一般選擇36～45例健康受試者開展生物等效性試驗；出于安全原因應采用小規(guī)格開展生物等效性研究，并做好受試者試驗期間的健康監(jiān)護；可采用平均生物等效性或參比制劑標度的平均生物等效性方法進行生物等效性評價，同時建議申請人提交受試制劑與參比制劑的達峰時間（t_max）的非參數檢驗結果。

Quetiapine Fumarate Tablet is used for the treatment of schizophrenia, which is a common drug for psychiatric diseases in clinic. Combined with the FDA and NMPA Quetiapine Fumarate Tablet bioequivalence test guidelines requires, based on recent years bioequivalence results summary and analysis in China, general review requirements was proposed for Quetiapine Fumarate Tablet bioequivalence test. It is recommended to use a two-agent, two-way, two-sequence crossover design to carry out fasting and fed human bioequivalence studies of single-dose, and also to use partial or complete repeat crossover design. Generally, 36 to 45 healthy subjects should be selected for fasting and fed bioequivalence of Quetiapine Fumarate Tablets, or to use partial or complete repeat crossover study design. For safety reasons, small strengths were used to related studies, and health monitoring of subjects should be done during the bioequivalence study. The average bioequivalence or the reference-scaled average bioequivalence method may be used for evaluation, and it is recommended that the applicant submit the non-parametric t_max test results of test and reference drug.

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