Exploration of screening criteria for healthy volunteers in human bioequivalence clinical trials / 中国临床药理学与治疗学

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.