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Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development pp 23–31Cite as

Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, Protein Binding, Mass Balance, Animal Models)

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Abstract

A careful evaluation of the pharmacokinetics and metabolism of a new drug should play an integral and continuing role in the nonclinical workup for that drug, and should be initiated very early in the drug development program. These studies are of primary importance for the planning and design of animal toxicity studies, and for the selection of the appropriate animal model for purposes of estimating a safe clinical dose. Examples of the usefulness of nonclinical pharmacokinetic data for explaining toxicity which occurred, while allowing clinical trials to continue, are presented.

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Author information

Authors and Affiliations

  1. Division of Neuropharmacological Drug Products Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, 20857, USA

    Glenna G Fitzgerald

Authors
  1. Glenna G Fitzgerald
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Editor information

Editors and Affiliations

  1. Pharmacodynamics Research, American Cyanamid Company, Medical Research, Pearl River, New York, USA

    Avraham Yacobi Ph.D. (Director) (Director)

  2. Office of Research Resources, Center for Drug Evaluation and Research, Food and Drug Administration, Washington, D.C., USA

    Jerome P. Skelly Ph.D. (Deputy Director) (Deputy Director)

  3. Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA

    Vinod P. Shah Ph.D. (Acting Deputy Associate Director for Science) (Acting Deputy Associate Director for Science)

  4. Department of Pharmacy, School of Pharmacy, University of California, San Francisco, San Francisco, California, USA

    Leslie Z. Benet Ph.D., Pharm.D.(Hon.) (Professor and Chairman) (Professor and Chairman)

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© 1993 Springer Science+Business Media New York

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Fitzgerald, G.G. (1993). Pharmacokinetics and Drug Metabolism in Animal Studies (ADME, Protein Binding, Mass Balance, Animal Models). In: Yacobi, A., Skelly, J.P., Shah, V.P., Benet, L.Z. (eds) Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-1520-0_4

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  • DOI: https://doi.org/10.1007/978-1-4757-1520-0_4

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4757-1522-4

  • Online ISBN: 978-1-4757-1520-0

  • eBook Packages: Springer Book Archive

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