阿立哌唑片生物等效性试验研究现状及其审评要求  

Progress and review requirement for Aripiprazole Tablet bioequivalence test in China

作　　者：刘冬 魏春敏 王骏 LIU Dong;WEI Chunmin;WANG Jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药物评价研究》2024年第1期10-16,共7页Drug Evaluation Research

摘　　要：阿立哌唑片主要用于精神分裂症的治疗,属精神类疾病临床常用药物。结合美国、中国该品种生物等效性试验指导原则要求,通过近年来在中国对阿立哌唑片开展的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:一般选择36例45岁以上健康受试者开展空腹及餐后生物等效性试验;出于安全原因采用10 mg规格开展相关研究,并应做好受试者试验期间的健康监护;药动学参数方面,可使用截断至72 h的药时曲线下面积(AUC)代替AUC0~t或AUC0~inf进行生物等效性的统计分析,2周期间应有足够长的清洗期;对于阿立哌唑口崩片除上述要求外,服药方式建议放置在舌头上使其崩解后无水吞服。Aripiprazole tablet is used for the treatment of schizophrenia,which is a common drug for psychiatric diseases in clinic.Combined with the United States and China Aripiprazole Tablet bioequivalence test guidelines requires,summary and analysis based on recent years bioequivalence result in China,and propose general review requirements for Aripiprazole Tablet bioequivalence test.Generally,about 36 healthy subjects over 45 years of age should be selected for fasting and fed bioequivalence of Aripiprazole Tablets.For safety reasons,10mg was used to carry out related studies,and health monitoring of subjects should be done during the bioequivalence.In terms of pharmacokinetic parameters,AUC truncated to 72 hours can be used instead of AUCo~,or AUCo~inr for statistical analysis of bioequivalence,and there should be sufficient long cleaning period during the two-week period.In addition to the above requirements,for aripiprazole orally disintegrating tablets should be administered without water.

关 键 词：阿立哌唑片 口腔崩解片 仿制药 生物等效性试验 审评要求 

分 类 号：R951[医药卫生—药学]