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Biosimilars: Comparative Analytical Assessment (U.S. Food and Drug Administration) View |
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Data Quality Expectations for Biosimilars with Case Studies (29of33) Quality – Oct. 16-17, 2019 (U.S. Food and Drug Administration) View |
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Biosimilars and Interchangeables - Regulatory Highlights (27of33) Quality – Oct. 16-17, 2019 (U.S. Food and Drug Administration) View |
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Biosimilar Comparability (ASMS 2013) (Waters Corporation) View |
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Biosimilars: Totality of the Evidence in Biosimilar Development (U.S. Food and Drug Administration) View |
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Biosimilars Part 2: Regulatory and Current Status (ClevelandClinicCME) View |
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02 THE US BIOSIMILARS REGULATORY PATHWAY (AmerGastroAssn) View |
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Comparison of Biologics to Biosimilars Versus Generics (The Center for Biosimilars) View |
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Assessing Biosimilarity Based on Ion Signal Statistics in LC/MS Peptide Maps (Waters Corporation) View |
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Strategies to Demonstrate Complex API Sameness (10of35) Complex Generics – Sep. 25-26, 2019 (U.S. Food and Drug Administration) View |