Regulatory agencies across the globe are encouraging the sponsors to come up with an early pediatric plan to support new drug approvals. One of the key challenges in pediatric drug development is defining an optimal dose for pediatric patients. Differences in volume of distribution, target-mediated drug disposition (for therapeutic proteins), ontogeny as well as abundance of drug-metabolizing enzymes or transporters (for small molecules) makes extrapolation of pediatric doses from adult data complicated. Each one of these factors should be carefully taken into consideration in order to propose an ideal dose and dosing type (BW-based, BSA-based, or fixed dose) for pediatric studies. The objective of this presentation is to highlight the importance of using model-informed drug development to design efficient dosing strategies for pediatric patients, based on two case examples, a monoclonal antibody and a small molecule.
Upon completion, participants will be able to appreciate the application of clinical pharmacology expertise in pediatric dose selection.
Upon completion, participants will be able to understand how to assess whether flat dosing, BSA-based, or BW-based dosing is appropriate for pediatric dosing of their molecule.
Upon completion, participants will be able to get an overview of what factors need to be considered in order to propose a starting dose in pediatric studies.