The FDA’s Rare Disease Framework Initiative brings risk-based CMC review and pre-approval inspections into scope for sponsors, CDMOs, and quality teams.
|Articles|October 24, 2011
Xiaoyu Yan: AAPS 2011 Profile
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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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