Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis 2020
Вставка
- Опубліковано 22 сер 2024
- 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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