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Testing Inhaled Generics

What role do new FDA guidance and productspecific US Pharmacopeia guidelines have to play in safeguarding the quality of popular drugs as they convert into generic products? Mark Copley at Copley Scientific investigates their importance in bioequivalence.

Mark Copley, Copley Scientific (December 2015)

Keywords: Bioequivalence, Inhaled route, Product-specific guidance, USP monographs, Aerodynamic particle size distribution

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