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Keyword Search Criteria: Biosimilar returned 5 record(s)
Monday, 07/30/2018
Evaluation of Regional Efficacy Equivalence in Developing Biosimilars
Ryuji Uozumi, Kyoto University Graduate School of Medicine; Shinjo Yada, A2 Healthcare Corporation
3:20 PM

Tuesday, 07/31/2018
Agreement and Individual Bioequivalence: A New Look
Tie-Hua Ng, FDA/CBER


Wednesday, 08/01/2018
A Reflection of the Statistical Assessment for Analytical Similarity and Beyond ----Are We Addressing the Right Question?
Aili Cheng, Pfizer
9:35 AM

Bayesian Framework for Tier 1 Analytical Biosimilarity Assessment
Yanbing Zheng, AbbVie; Hesham Fahmy, AbbVie
9:50 AM

Thursday, 08/02/2018
On Sample Size Requirement for Analytical Similarity Assessment
Victoria Chang, AbbVie; Yi Zhao, Statistics Collaborative; Shein-Chung Chow, Food and Drug Administration
10:50 AM