What is it about?
It is a descriptive study to show the most common size of bioequivalence studies in the different drug development phases registered in USA, Europe, Japan and Australia.
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Why is it important?
It is not easy to calculate the size of a bioequivalent study to be statistically sure that similarity can be demonstrated.
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This page is a summary of: FIP Seville 2022: Industrial Pharmacy, Pharmacy Education, August 2023, International Pharmaceutical Federation (FIP),
DOI: 10.46542/pe.2023.233.240242.
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