Allometric issues in drug development.

J Pharm Sci

Office of Clinical Pharmacology and Biopharmaceutics, Division of Pharmaceutical Evaluation I (HFD-860), Food & Drug Administration, Woodmont Office Center II, Room 4079, 1451 Rockville Pike, Rockville, Maryland 20852, USA.

Published: November 1999

The concept of correlating pharmacokinetic parameters with body weight from different animal species has become a useful tool in drug development. The allometric approach is based on the power function, where the body weight of the species is plotted against the pharmacokinetic parameter(s) of interest. Clearance, volume of distribution, and elimination half-life are the three most frequently extrapolated pharmacokinetic parameters. Over the years, many approaches have been suggested to improve the prediction of these pharmacokinetic parameters in humans from animal data. A literature review indicates that there are different degrees of success with different methods for different drugs. Overall, though interspecies scaling requires refinement and better understanding, the approach has lot of potential during the drug development process.

Download full-text PDF

Source
http://dx.doi.org/10.1021/js9902163DOI Listing

Publication Analysis

Top Keywords

pharmacokinetic parameters
16
drug development
12
body weight
8
allometric issues
4
issues drug
4
development concept
4
concept correlating
4
pharmacokinetic
4
correlating pharmacokinetic
4
parameters
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!