中国临床药理学杂志2024，Vol.40Issue(17)：2606-2608,3.DOI:10.13699/j.cnki.1001-6821.2024.00.031
哌柏西利片人体生物等效性研究相关考虑
Considerations of palbociclib tablets in human bioequivalence study
贺锐锐 1刘少丹 1魏春敏 1王骏1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京,100076
- 折叠
摘要
Abstract
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.关键词
抗酸药/pH依赖溶解性/生物等效性Key words
antacids/pH-dependent solubility/bioequivalence分类
医药卫生引用本文复制引用
贺锐锐,刘少丹,魏春敏,王骏..哌柏西利片人体生物等效性研究相关考虑[J].中国临床药理学杂志,2024,40(17):2606-2608,3.
