Dose Conversion Between Animals and Humans: A Practical Solution

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.