The dose conversion tool facilitates the conversion of doses of test substances between animals and humans based on body surface area (BSA), as outlined in the FDA’s 2005 guidance on estimating the maximum safe starting dose in initial clinical trials. It supports translational research by enabling accurate interspecies dose scaling from common laboratory animals such as mice, rats, dogs, monkeys, and humans. To know how this dose conversion tool works and its background, you may refer to this blog on Dose Conversion.
This dose conversion tool is also useful in the preparation of Generally Recognized as Safe (GRAS) dossiers and New Dietary Ingredient (NDI) notifications, enabling acceptable extrapolation of animal study doses to human equivalents. Ideal for regulatory submissions, safety assessments, and dosage justification in product development.
Guidance for Industry: Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers. Center for Drug Evaluation and Research (CDER), Food and Drug Administration, the U.S. Department of Health and Human Services, July 2005.
Disclaimer: The Dose Conversion Tool must not be used by consumers to determine personal dosing or to assume safety of any ingredient or product as it do not account for required safety factors, target population considerations, intended use, or regulatory toxicology standards. Appropriate safety assessment, expert review, and regulatory compliance are essential for any clinical, therapeutic, or consumer use.