Xiaoyu Yan: AAPS 2011 Profile
Xiaoyu Yan
Yan is a PhD Candidate at the Department of Pharmaceutical Sciences, University at Buffalo, the State University of New York. His research work is focused on the pharmacokinetic and pharmacodynamic modeling of erythropoiesis-stimulating agents. His presented work is about using population modeling and simulation approach to assess the comparability between a Recombinant Human Epoetin Alfa and the Biosimilar HX575.
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Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
