Exploration of screening criteria for healthy volunteers in human bioequivalence clinical trials

Author: Yuchen SUN ¹ ; Yinhui LIU ¹ ; Xian ZHANG ¹ ; Tong YUAN ¹ ; Mengyao JING ¹ ; Xinyu ZHANG ¹ ; Jin YANG ¹
Author Information

1. Center of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University
Publication Type:Journal Article
Keywords: Exclusion criteria; Healthy volunteers; Human bioequivalence test; Inclusion criteria; Screening failure rate
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(6):714-720
CountryChina
Language:Chinese
Abstract: Human bioequivalence testing is an important part of evaluating the quality of a formulation. Although these drugs have a large amount of safety data and clinical application data, they may still have ethical risks in healthy subjects. The definition of healthy volunteers, the general inclusion and exclusion criteria, auxiliary inclusion and exclusion criteria, and inclusion and exclusion criteria considering drug specificity are summarized. The basis for determining whether abnormal test values are clinically significant when screening healthy subjects and the considerations for improving the screening pass rate are discussed. It is expected to provide useful reference for the smooth implementation of human bioequivalence testing.