摘要
富马酸喹硫平片主要用于治疗精神分裂症、双相情感障碍的躁狂发作,属精神类疾病临床常用药物。结合美国及中国该品种生物等效性试验指导原则要求,通过对近年来中国富马酸喹硫平片开展生物等效性试验结果进行总结、分析,并对本品种生物等效性试验提出审评的一般要求如下:建议采用两制剂、两周期、两序列交叉设计,开展单次给药的空腹及餐后人体生物等效性研究,也可采用部分重复或完全重复交叉试验设计;一般选择36~45例健康受试者开展生物等效性试验;出于安全原因应采用小规格开展生物等效性研究,并做好受试者试验期间的健康监护;可采用平均生物等效性或参比制剂标度的平均生物等效性方法进行生物等效性评价,同时建议申请人提交受试制剂与参比制剂的达峰时间(tmax)的非参数检验结果。
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 tmax test results of test and reference drug.
作者
刘冬
李娜
张丹
王骏
LIU Dong;LI Na;ZHANG Dan;WANG Jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)
出处
《药物评价研究》
CAS
北大核心
2024年第4期679-686,共8页
Drug Evaluation Research
关键词
富马酸喹硫平片
缓释片
仿制药
生物等效性试验
审评要求
Quetiapine Fumarate Tablet
extended release tablet
generic drug
bioequivalence test
review requirement
