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The Use of Toxicokinetic Data in Preclinical Safety Assessment: A Toxicologic Pathologist Perspective

¹ Department of Toxicology & Drug Disposition, Organon, 5340 BH Oss, The Netherlands
² Clinical Pharmacology & Kinetics, Organon, 5340 BH Oss, The Netherlands
³ Department of Pharmacology, Organon Research, Scotland

Correspondence: Address correspondence to: Jan-Peter Ploemen, Department of Toxicology & Drug Disposition, Organon, PO Box 20, 5340 BH Oss, The Netherlands; e-mail:jan-peter.ploemen{at}organon.com

Collection of toxicokinetic data has become a routine practice during the last 15 years in most general toxicity studies on pharma. It enables the correlation of pathological changes with the plasma concentration of drugs and/or their metabolites. This overview summarizes the use of the toxicokinetic data from the perspective of the toxicologic pathologist.

Key Words: Pharmacokinetics • drug development • risk assessment • toxicokinetics • toxicological pathology

Abbreviations: C_max, maximum plasma concentration of drug, reached at a certain time (T_max) • AUC, the area under the plasma concentration versus time curve • t, elimination half-life • F, oral bioavailability

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