PT  - JOURNAL ARTICLE
AU  - Lin, Jiunn H.
TI  - Applications and Limitations of Interspecies Scaling and <em>In Vitro</em> Extrapolation in Pharmacokinetics
DP  - 1998 Dec 01
TA  - Drug Metabolism and Disposition
PG  - 1202--1212
VI  - 26
IP  - 12
4099  - http://dmd.aspetjournals.org/content/26/12/1202.short
4100  - http://dmd.aspetjournals.org/content/26/12/1202.full
SO  - Drug Metab Dispos1998 Dec 01; 26
AB  - 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 vitroextrapolation in pharmacokinetics. The American Society for Pharmacology and Experimental Therapeutics