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Vol. 26, Issue 12, 1202-1212, December 1998

Applications and Limitations of Interspecies Scaling and In Vitro Extrapolation in Pharmacokinetics

Jiunn H. Lin

Department of Drug Metabolism, Merck Research Laboratories

The search for new drugs is an extremely time-consuming and costly endeavor. Much of the time and cost are expended on generating data that support the efficacy and safety profiles of the drug. Because of ethical constraints, relevant pharmacological and toxicological assessments must be made in laboratory animals and in in vitro systems before human testing can begin. In support of the efficacy and safety evaluation during drug development, two fundamental challenges facing industrial drug metabolism scientists are (1) how to "scale-up" the pharmacokinetic data from animals to humans and (2) how to extrapolate the in vitro data to the in vivo situation. This review examines the applications and limitations of interspecies scaling and in vitro extrapolation in pharmacokinetics.

Copyright © 1998 by The American Society for Pharmacology and Experimental Therapeutics


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Copyright © 1998 by the American Society for Pharmacology and Experimental Therapeutics.