General considerations for the design of bioequivalence studies of etomidate medium/long-chain fat emulsion injection
10.13699/j.cnki.1001-6821.2024.00.031
- VernacularTitle:依托咪酯中/长链脂肪乳注射液生物等效性研究设计的一般考虑
- Author:
Na AN
1
;
Dong LI
;
Li-Li LIU
;
Fang LI
;
Li-Li HA
;
Man-Ru REN
;
Yu ZHOU
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Keywords:
etomidate;
generic drugs;
bioequivalence studies;
security
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(10):1541-1544
- CountryChina
- Language:Chinese
-
Abstract:
Etomidate reversibly blocks 11-β-hydroxylated steroid dehydrogenase inhibits the synthesis of cortisol by adrenal cells.This product is a special injection.When evaluating the quality and efficacy of the generic and the reference preparations,it should be based on pharmaceutical and non-clinical consistency and adopt a step-by-step research strategy,firstly,bioequivalence(BE)was studied.In bioequivalence study,the research type,dosage and method,bioequivalence evaluation,safety monitoring and pharmacodynamics(PD)evaluation should be considered and designed reasonably.Based on the pharmacokinetics(PK)characteristics of etomidate medium-long chain fat emulsion injection and the bioequivalence study of its generic drug before its domestic market,the general design requirements and relevant considerations for the bioequivalence study of this product were systematically discussed.The purpose is to provide useful reference and guidance for domestic research and development of generic drugs.
