中国临床药理学杂志2024，Vol.40Issue(2)：273-275,3.DOI:10.13699/j.cnki.1001-6821.2024.02.025
食物影响研究中高脂餐的配制与改良
Formulation and modification of high-fat meals in food impact studies
摘要
Abstract
The food effect(FE)on drug absorption is an important part of clinical pharmacological studies of new drugs.The caloric ratios for each component of a high-fat meal are specified in the"Technical Guidelines for Food Bioavailability and Postprandial Bioequivalence Studies"approved by the US Food and Drug Administration(FDA)and the"Technical Guidelines for Food Effect Studies in New Drug Development"approved by the National Medical Products Administration.However,the recipes for high-fat meals vary among clinical research centers,showing their advantages and disadvantages.Thus,we present a modified version of high-fat meal recipes with easy-to-quantify calories,which is a combination of Western and Chinese flavors,easy to prepare,and meets Chinese tastes.The center satisfaction surveys showed that our modified version of the high-fat meal recipe greatly improved subject satisfaction and compliance,thus better safeguarding the quality of the trial.关键词
食物影响/高热量高脂肪/高脂餐/生物利用度Key words
food effect/high-calorie and high-fat/high-fat meal/bioavailability分类
医药卫生引用本文复制引用
蒋倩倩,张薇,项笑娜,黄珺,江波,杨丹丹..食物影响研究中高脂餐的配制与改良[J].中国临床药理学杂志,2024,40(2):273-275,3.基金项目
国家卫生健康委重大新药创制国家科技重大专项基金资助项目(2020ZX09201022) （2020ZX09201022）
