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

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

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...

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Bibliographic Details
Main Authors: Ki Young Huh, Eunwoo Kim, Soyoung Lee, Hyounggyoon Yoo, Seonghae Yoon, Kyung-Sang Yu, Jae-Yong Chung
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-05-01
Series:Frontiers in Pharmacology
Subjects:
bioequivalence
regulations
generic drug
Intrasubject coefficient of variation
biopharmaceutics classification system
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2021.651790/full

Internet

https://www.frontiersin.org/articles/10.3389/fphar.2021.651790/full

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