Subject Selection and Safety Considerations in Human Bioequivalence Study

Human bioequivalence study is an essential step in the development of generic formulations. Although these drugs have comprehensive safety profiles and well-established clinical application, they may cause adverse effects in healthy volunteers due to their expected pharmacologic effects. The criteria of selecting healthy volunteers, potential adverse effects in human bioequivalence study and corresponding precautions, as well as the processing of abnormal values in clinical trial were reviewed in this article.