In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies

Elizabeth Bielski from the Office of Generic Drugs discusses the agency’s current perspectives on comparative clinical endpoint BE studies with Orally Inhaled and Nasal Drug Products (OINDPs), as well as the agency’s efforts to address its challenges through alternative BE approaches. The alternative BE approaches recommended in recently posted product-specific guidances (PSGs) for solution-based Metered Dose Inhalers (MDIs) will be described, along with brief discussions on supporting data, critical study parameters, and the potential for expanding alternative BE approaches to more complex orally inhaled products.

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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