Accurate prediction of the pediatric dose is a necessity before conducting a clinical trial or using a drug product in standard clinical practices. For the pediatric population, safety and efficacy need to be considered for ethical reasons. The recommended doses of most of the therapeutic proteins, including monoclonal antibodies (mAbs), are extrapolated to pediatrics from adult doses based on body weight. This approach does not consider physiological and biochemical differences between children and adults. mAbs’ underexposure, limiting its efficacy in this population, is therefore possible. Other methods are necessary to mechanistically predict pediatric doses. For small molecules, physiologically based pharmacokinetic (PBPK) models have been long used to predict pediatric dose based on age-related changes in the physiology and enzymes/transporters ontogeny.
By Chiara Zunino, Jérémy Perrier, Virginie Gualano, Haiying Zhou, Viera Lukacova, Maxime Le Merdy
Presented Tuesday, April 25th, 2023 AAPS National Biotechnology Conference, Philadelphia, PA