2018 ASA Biopharm Section Statistics Workshop Population bioequivalence, in-vitro bioequivalence and CMC or analytical equivalence Yi Tsong, CDER, FDA Disclaimer: This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies. 2018 ASA Biopharm Section Statistics Workshop

2018 ASA Biopharm Section Statistics Workshop Outline Average Bioequivalence Test Individual Bioequivalence Test Population Bioequivalence Test Reference Scaled Average Bioequivalence Test In-Vitro Equivalence Test Conclusion and Summary 2018 ASA Biopharm Section Statistics Workshop

Average Bioequivalence 2018 ASA Biopharm Section Statistics Workshop

2018 ASA Biopharm Section Statistics Workshop

Individual Bioequivalence 2018 ASA Biopharm Section Statistics Workshop

2018 ASA Biopharm Section Statistics Workshop

Population Bioequivalence and In-vitro BE 2018 ASA Biopharm Section Statistics Workshop

2018 ASA Biopharm Section Statistics Workshop

Reference Scaled Average Bioequivalence 2018 ASA Biopharm Section Statistics Workshop

2018 ASA Biopharm Section Statistics Workshop

Summary and Conclusion 2018 ASA Biopharm Section Statistics Workshop

2018 ASA Biopharm Section Statistics Workshop Potential Solution 2018 ASA Biopharm Section Statistics Workshop

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