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FDA anti-asthma drug bioequivalence guidance

Executive Summary

Outlines protocol for testing metaproterenol sulfate and albuterol metered dose inhalers in a randomized, single dose, two-way, crossover study of 60 mild-to-moderate asthmatics. Copies of the guidance are available from FDA's Division of Bioequivalence, Parklawn Building, 5600 Fishers Lane, Rockville, MD.

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