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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Main Authors: | Ki Young Huh (Author), Eunwoo Kim (Author), Soyoung Lee (Author), Hyounggyoon Yoo (Author), Seonghae Yoon (Author), Kyung-Sang Yu (Author), Jae-Yong Chung (Author) |
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Format: | Book |
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Frontiers Media S.A.,
2021-05-01T00:00:00Z.
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