对乙酰氨基酚片质量与疗效一致性评价综述  

A Review on Quality and Efficacy Consistency Evaluation of Paracetamol Tablets

作　　者：张涛 张梦 郝建平 高雁平 李建伟 ZHANG Tao;ZHANG Meng;HAO Jianping;GAO Yanping;LI Jianwei(School of Pharmacy,Fudan University,Shanghai 201203;Beijing Zhendong Biological Technology Co.,Ltd.,Beijing 100080;Research Institute of Frontier and Interdisciplinary Sciences,Peking University,Beijing 100871)

机构地区：[1]复旦大学药学院,上海201203 [2]北京振东生物科技有限公司,北京100080 [3]北京大学前沿交叉学科研究院,北京100871

出　　处：《中国医药工业杂志》2021年第10期1304-1312,共9页Chinese Journal of Pharmaceuticals

摘　　要：本文概括总结了对乙酰氨基酚片参比制剂的上市历史,仿制药质量与疗效一致性评价相关的药政法规变化、药动学参数以及体内外相关性研究资料,并且简要总结了国家药品监督管理局豁免对乙酰氨基酚片生物等效性研究、仅需与参比制剂进行药学等效性研究的文献依据。This paper is a summarization for marketing history of the paracetamol-containing reference listed drug(RLD),the changes in pharmaceutical regulations related to quality and efficacy consistency evaluation,pharmacokinetic parameters and in vitro-in vivo correlation research data of generic paracetamol tablets.And this paper briefly summarizes the literature basis for generic paracetamol tablets exempted from bioequivalence studies according to the National Medical Products Administration guidance,and the regulatory approval of the generic tablets only requires the consistency of pharmaceutical equivalence studies to the RLD.

关 键 词：对乙酰氨基酚 片剂 仿制药 质量一致性评价 生物等效性 

分 类 号：R944.4[医药卫生—药剂学]