Current Bioequivalence Study Designs in South Korea: A Comprehensive Analysis of Bioequivalence Study Reports Between 2013 and 2019

• Autors principals: Ki Young Huh (Autor), Eunwoo Kim (Autor), Soyoung Lee (Autor), Hyounggyoon Yoo (Autor), Seonghae Yoon (Autor), Kyung-Sang Yu (Autor), Jae-Yong Chung (Autor)
• Format: Llibre
• Publicat: Frontiers Media S.A., 2021-05-01T00:00:00Z.
• Matèries: article
• Accés en línia: Connect to this object online.

Demonstration of bioequivalence (BE) is mandatory while developing generic drugs. The scientific concept of BE applies equally to different regulatory agencies. However, the application of the concept may differ for each agency, which can affect the design of BE studies. To evaluate the study practi...