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-education-industry-advancing-innovative-science-generic-drug-development-workshop
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