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A History of Biopharmaceutics in the Food and Drug Administration 1968–1993

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  • Theme: Pharmacokinetics, Biopharmaceutics and Bioequivalence: History and Perspectives
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Abstract

The history of biopharmaceutics is reviewed, beginning with its origin out of the Division of Clinical Research in The Bureau of Medicine. The reason for the creation of the Division of Biopharmaceutics, the certification of Food and Drug Administration authority over the functions it was to have, and the implementation of that authority are described. The determination of bioequivalence, the bioavailability decision rules, pharmacokinetics, and drug metabolism are explained. The reason for the development of the Scale-Up and Post Approval Regulations and how they were developed are also explained.

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Authors and Affiliations

  1. 9321 Coral Lane, Alexandria, Virginia, 22309, USA

    Jerome Philip Skelly

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  1. Jerome Philip Skelly
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Correspondence to Jerome Philip Skelly.

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Guest Editors: Marilyn Martinez and Lawrence Yu

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Skelly, J.P. A History of Biopharmaceutics in the Food and Drug Administration 1968–1993. AAPS J 12, 44–50 (2010). https://doi.org/10.1208/s12248-009-9154-8

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  • DOI: https://doi.org/10.1208/s12248-009-9154-8

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