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Drug Metabolism and Disposition Fast Forward
First published on April 21, 2008; DOI: 10.1124/dmd.108.020479

0090-9556/08/3607-1385-1405$20.00
DMD 36:1385-1405, 2008

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Trend Analysis of a Database of Intravenous Pharmacokinetic Parameters in Humans for 670 Drug CompoundsFormula

R. Scott Obach, Franco Lombardo, and Nigel J. Waters

Pharmacokinetics Dynamics and Metabolism, Pfizer Global Research and Development, Groton Laboratories, Groton, Connecticut (R.S.O.); and Metabolism and Pharmacokinetics Groups, Novartis Institutes for Biomedical Research, Cambridge, Massachusetts (F.L.) and Horsham, West Sussex, United Kingdom (N.J.W.)

We present herein a compilation and trend analysis of human i.v. pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data. This data set provides the drug metabolism scientist with a robust and accurate resource suitable for a number of applications, including in silico modeling, in vitro-in vivo scaling, and physiologically based pharmacokinetic approaches. Clearance, volume of distribution at steady state, mean residence time, and terminal phase half-life were obtained or derived from original references exclusively from studies utilizing i.v. administration. Plasma protein binding data were collected from other sources to supplement these pharmacokinetic data. These parameters were analyzed concurrently with a range of simple physicochemical descriptors, and resultant trends and patterns within the data are presented. Our findings with this much expanded data set were consistent with earlier described notions of trends between physicochemical properties and pharmacokinetic behavior. These observations and analyses, along with the large database of human pharmacokinetic data, should enable future efforts aimed toward developing quantitative structure-pharmacokinetic relationships and improving our understanding of the relationship between fundamental chemical characteristics and drug disposition.

Address correspondence to: Franco Lombardo, Novartis Institutes for Biomedical Research, Building 600, 1B-123, 250 Massachusetts Avenue, Cambridge, MA 02139. E-mail: franco.lombardo{at}novartis.com




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