Biosimilars: Critical Quality Attributes

U.S. Food and Drug Administration
U.S. Food and Drug Administration
7.5 هزار بار بازدید - 3 سال پیش - What are critical quality attributes?
What are critical quality attributes? This video discusses Comparative analytical studies between the proposed biosimilar and its reference product that comprehensively evaluate structural and functional characteristics called critical quality attributes. These are attributes that can impact the overall quality and clinical performance of the product.  For more information, visit www.FDA.gov/biosimilars.
3 سال پیش در تاریخ 1400/09/26 منتشر شده است.
7,532 بـار بازدید شده
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