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J Pharm Sci. 1999 Nov;88(11):1101-6.

Allometric issues in drug development.

Author information

1
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. Mahmoodi@CDER.FDA.GOV

Abstract

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.

PMID:
10564055
DOI:
10.1021/js9902163
[Indexed for MEDLINE]

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