丙泊酚脂肪乳注射液生物等效性研究的设计考量和实施要素

Design strategies and critical implementation points for bioequivalence studies of propofol fat emulsion injection

丙泊酚是目前临床上广泛使用的全身麻醉诱导剂和维持剂,以快速起效和停药后快速恢复为特征。丙泊酚在我国和欧美等多个国家和地区已上市多年。随着丙泊酚专利到期,许多国内外药企都投入了丙泊酚仿制药的开发。本文首先回顾了丙泊酚脂肪乳注射液的药代动力学特征和临床使用情况,进而综述已发表丙泊酚生物等效性试验的设计和结果,并对美国食品药品监督管理局发布的丙泊酚个药生物等效性指南进行解读,最后总结并阐述丙泊酚生物等效性试验的设计考量和实施要素。

Propofol is a fast-acting and well-tolerated intravenous anesthetic for use in the induction and maintenance of anesthesia or sedation. Propofol has been on the market for many years in China, Europe, the United States and many other countries. The patient of the original propofol was expired, thereafter many pharmaceutical companies initiated their clinical development on propofol generic drugs. This review first summarizes the pharmacokinetic and clinical properties of propofol fat emulsion injection, then reviews publications of propofol bioequivalence studies regarding their design and results and collaborate these elements with the U.S. Food and drug administration draft guideline on propofol BE study. The manuscript aims to propose design strategies and critical implementation points for bioequivalence studies with propofol.