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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Detalles Bibliográficos
Autores principales: Huh, Ki Young, Kim, Eunwoo, Lee, Soyoung, Yoo, Hyounggyoon, Yoon, Seonghae, Yu, Kyung-Sang, Chung, Jae-Yong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Pharmacology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147690/
https://www.ncbi.nlm.nih.gov/pubmed/34045962
http://dx.doi.org/10.3389/fphar.2021.651790

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8147690/
https://www.ncbi.nlm.nih.gov/pubmed/34045962
http://dx.doi.org/10.3389/fphar.2021.651790

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