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FDA/Johns Hopkins inhaled albuterol study contract

Executive Summary

Hopkins School of Medicine is expected to begin pilot studies in April to assess different study designs to determine bioequivalence of generic albuterol metered dose inhaler products. The studies are expected to help FDA's Office of Generic Drugs in developing an in vivo bioequivalence guidance ("The Pink Sheet" Oct. 21, 1991, T&G-11).

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