Data Requirements for Biosimilars

U.S. Food and Drug Administration
U.S. Food and Drug Administration
26.5 هزار بار بازدید - 6 سال پیش - FDA-approved biosimilars require data from
FDA-approved biosimilars require data from multiple studies and analytical tools to demonstrate analytical similarity to reference products. Learn more with Dr. Steve Kozlowski, M.D., Director at FDA’s Center for Drug Evaluation and Research. For more information, visit https://www.FDA.gov/biosimilars
6 سال پیش در تاریخ 1397/03/01 منتشر شده است.
26,545 بـار بازدید شده
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