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

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.
Learn more at www.fda.gov/drugs/regulatory-...
_______________________________
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
Upcoming Training - www.fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accoun...
SBIA 2020 Playlist - • 2020 CDER Small Busine...
SBIA LinkedIn - / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cderbsbialearn
Twitter - / fda_drug_info
Email - [e-mail]
Phone - [phone] I [phone]