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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...
Autores principales: | Huh, Ki Young, Kim, Eunwoo, Lee, Soyoung, Yoo, Hyounggyoon, Yoon, Seonghae, Yu, Kyung-Sang, Chung, Jae-Yong |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
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 |
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