Bioequivalence Regulations and Product-Specific Guidances 

Dave Coppersmith from the Office of Generic Drug Policy discusses bioequivalence (BE) regulatory requirements and how they relate to product specific guidances (PSGs), the availability of alternative approaches to recommendations in PSGs, in vivo and in vitro BE testing requirements, and how FDA revises PSGs.
Learn more at www.fda.gov/drugs/fda-product...
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