"This effort aims to stimulate research in a major gap area in pediatric psychopharmacology for psychiatric and neurodevelopmental disorders, by encouraging the development of objective pediatric central nervous system (CNS) measures that can be incorporated into pharmacologic trials. The development of these measures/biomarkers can aid in dose selection for future efficacy trials or enable subgroup stratification to identify which subjects respond better or worse to a particular agent. Overall, this research will improve the safety of prescribed medication in youth populations."
"Over the last decade, limited drugs have been approved for the treatment of psychiatric and neurodevelopmental disorders in youth. There is a need for more objective measures to be built into early-stage pediatric trials (Phase I/II Proof of Concept studies) to ensure that the dosing used in these and in subsequent registration trials is optimal to test the drug mechanism in question."
Objective pediatric CNS measures and biomarkers are needed to improve pediatric psychopharmacology by enabling dose selection and subgroup stratification in clinical trials. Limited drug approvals and lack of validated pediatric pharmacodynamic (PD) measures hinder optimal dosing and testing of drug mechanisms in youth. Advances in CNS imaging and EEG could enable objective PD assessment, but validated pediatric measures are not yet established. Pairing PD measures with pharmacokinetic (PK) data supports PK/PD modeling to define CNS dose-response relationships. These approaches facilitate bridging from adult data, direct pediatric drug-action assessment, and improved medication safety for youth.
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