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Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis 2020 

U.S. Food and Drug Administration
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Salaheldin S. Hamed, CDER Office of Clinical Pharmacology, provides an introduction to biosimilars to include submission components and bioanalysis. He shares recommendations and the following case examples: bioanalysis platform, validation: QC, SC, and Long-term stability, and validation: SC.
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17 окт 2024

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