Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method

U.S. Food and Drug Administration
U.S. Food and Drug Administration
10.6 هزار بار بازدید - 4 سال پیش - Xiajing Gong from the Office
Xiajing Gong from the Office of Generic Drugs discusses provides a comprehensive review on similarity factor (f2), f2 bootstrapping and multivariate statistical distance (MSD) methods for dissolution similarity assessment, including mathematical definition and assumption, conditions of use and interpretation of results. Some case examples are discussed in this presentation.


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4 سال پیش در تاریخ 1399/09/03 منتشر شده است.
10,623 بـار بازدید شده
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