Considerations of palbociclib tablets in human bioequivalence study
10.13699/j.cnki.1001-6821.2024.00.031
- VernacularTitle:哌柏西利片人体生物等效性研究相关考虑
- Author:
Rui-Rui HE
1
;
Shao-Dan LIU
;
Chun-Min WEI
;
Jun WANG
Author Information
1. 国家药品监督管理局药品审评中心,北京,100076
- Keywords:
antacids;
pH-dependent solubility;
bioequivalence
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(17):2606-2608
- CountryChina
- Language:Chinese
-
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.
