Meng Hu from the Office of Generic Drugs discusses quantitative methods for comparing particle size distributions to demonstrate equivalence. This includes the considerations and use of the appropriate descriptors for particle size histograms and the following statistical equivalence method, such as the Population Bioequivalence (PBE), under different scenarios (e.g., monomodal vs. complex distribution profile).
Learn more at https://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 https://www.fda.gov/cdersbia
SBIA Listserv https://public.govdelivery.com/accoun...
SBIA 2020 Playlist https://www.youtube.com/playlist?list...
SBIA LinkedIn / cdersmallbusinessandindustryassistance
SBIA Training Resources https://www.fda.gov/cderbsbialearn
Twitter / fda_drug_info
Email [email protected]
Phone (301) 7966707 I (866) 4055367