摘要
哌柏西利片是由哌柏西利胶囊进行处方工艺优化后获得的改良产品,能够降低抗酸药对哌柏西利暴露的影响。与胶囊剂餐后服药的要求不同,哌柏西利片可以在不考虑食物摄入的情况下给药。由于其独特的生物药剂学特性,哌柏西利片的人体生物等效性研究要求与普通仿制药有所不同。本文通过解析哌柏西利的药物特征、胶囊和片剂的生物药剂学特点,提出哌柏西利片仿制药的人体生物等效性研究建议,为我国哌柏西利片的仿制研究提供参考。
Palbociclib tablet is an improved product obtained by optimizing the prescription process of palbociclib capsule,which can reduce the impact of antacids on piperacillin exposure.Unlike the postprandial medication requirements for the capsule formulation,tablets can be administered without considering food intake.Due to its unique biopharmaceutical properties,the research requirements for human bioequivalence(BE)study of palbociclib tablets are different from those of regular generic drugs.This article analyzes the drug characteristics of palbociclib,as well as the biopharmaceutical characteristics of the capsule and the tablet,and proposes research recommendations for the bioequivalence of generic palbociclib tablets in human,providing reference for the generic research of palbociclib tablets in China.
作者
贺锐锐
刘少丹
魏春敏
王骏
HE Rui-rui;LIU Shao-dan;WEI Chun-min;WANG Jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2024年第17期2606-2608,共3页
The Chinese Journal of Clinical Pharmacology
