Dose Conversion Between Animals and Humans: A Practical Solution

Indian Journal of Pharmaceutical Education and Research

  • Shery Jacob1Department of Pharmaceutical Sciences, College of Pharmacy, Gulf Medical University, Ajman, UAE.
  • Anroop B Nair2Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, SAUDI ARABIA.
  • Mohamed A Morsy2Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, SAUDI ARABIA., 3Department of Pharmacology, Faculty of Medicine, Minia University, El-Minia, EGYPT.

Volume 56 Issue 3 Pages 600-607

DOI: 10.5530/ijper.56.3.108

Abstract

Selecting the most appropriate first-in-human and pharmacologically active dose for any new drugs or biologicals is a crucial step before starting a clinical trial investigation in adult healthy human subjects. Extrapolation of dose between various rodent and non-rodent animal species is critical for biomedical researchers during initial drug development. The objective of this review is to provide practical guidance on how allometric scaling based on the body surface area normalization can be effectively utilized for dose conversion between various animal species. The standard conversion factors are included to allow dose translation between animals to humans and humans to animals expressed either in mg/kg or mg/m2. The estimation of a safe starting dose is important to ensure the safety and tolerability of humans during phase-I clinical trials.

Keywords

  • Starting dose
  • Body surface area
  • Dose translation
  • Human equivalent dose
  • Animal equivalent dose
  • Interspecies dose conversion
  • Allometric scaling
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