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Allometric issues in drug development.

I Mahmood1

  • 1Office 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

Journal of Pharmaceutical Sciences
|November 17, 1999
PubMed
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Interspecies scaling using allometry helps predict drug pharmacokinetic parameters across species. This method, correlating body weight with parameters like clearance, shows potential in drug development despite needing refinement.

Area of Science:

  • Pharmacokinetics and Drug Development
  • Allometric Scaling in Preclinical Research

Background:

  • Correlating pharmacokinetic parameters with body weight across species is a valuable tool in drug development.
  • The allometric approach, utilizing a power function, is commonly employed for this correlation.

Purpose of the Study:

  • To review and assess the utility of interspecies scaling for predicting human pharmacokinetic parameters from animal data.
  • To highlight the importance of pharmacokinetic parameters such as clearance, volume of distribution, and elimination half-life.

Main Methods:

  • Literature review of various interspecies scaling approaches.
  • Analysis of the allometric method, which plots species body weight against pharmacokinetic parameters.
  • Focus on key parameters: clearance, volume of distribution, and elimination half-life.

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Main Results:

  • Different methods show varying degrees of success for different drugs.
  • The allometric approach is frequently used for extrapolating key pharmacokinetic parameters.
  • Successful prediction of human pharmacokinetics from animal data remains a challenge.

Conclusions:

  • Interspecies scaling, particularly the allometric approach, holds significant potential in drug development.
  • Further refinement and a deeper understanding of interspecies scaling methods are necessary for improved accuracy.
  • The approach aids in predicting crucial pharmacokinetic parameters across different animal species.