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Toxicologic Pathology
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Brief Communication

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

Jan-Peter H. T. M. Ploemen1, Hester Kramer2, Ernö I. Krajnc1 and Iain Martin3

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: Cmax, maximum plasma concentration of drug, reached at a certain time (Tmax) • AUC, the area under the plasma concentration versus time curve • t1/2, elimination half-life • F, oral bioavailability

Toxicologic Pathology, Vol. 35, No. 6, 834-837 (2007)
DOI: 10.1080/01926230701584247
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