Formulation and modification of high-fat meals in food impact studies
10.13699/j.cnki.1001-6821.2024.02.025
- VernacularTitle:食物影响研究中高脂餐的配制与改良
- Author:
Qian-Qian JIANG
1
;
Wei ZHANG
;
Xiao-Na XIANG
;
Jun HUANG
;
Bo JIANG
;
Dan-Dan YANG
Author Information
1. 浙江大学医学院附属第二医院护理部,浙江杭州 310009
- Keywords:
food effect;
high-calorie and high-fat;
high-fat meal;
bioavailability
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(2):273-275
- CountryChina
- Language:Chinese
-
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.
