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

  • Glenna G Fitzgerald


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.


Parent Drug Toxicity Study Drug Plasma Level Drug Development Program Tissue Distribution Study 
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Copyright information

© Springer Science+Business Media New York 1993

Authors and Affiliations

  • Glenna G Fitzgerald
    • 1
  1. 1.Division of Neuropharmacological Drug Products Center for Drug Evaluation and ResearchFood and Drug AdministrationRockvilleUSA

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