A Call for Objective Dose Selection to Increase Success in Pediatric Clinical Trials: A Perspective From NICHD and NIMH Program Staff

J Clin Pharmacol. 2021 Jun:61 Suppl 1:S9-S12. doi: 10.1002/jcph.1849.

¹ Obstetric and Pediatric Pharmacology and Therapeutics Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Bethesda, Maryland, USA.
² National Institute of Mental Health (NIMH), Bethesda, Maryland, USA.

No abstract available

Keywords: Clinical Pharmacology (CPH); Clinical Trials (CTR); MIDD (model informed drug development); PBPK; Pediatrics (PED); Pharmacometrics.

MeSH terms

Clinical Trials as Topic / organization & administration*
Clinical Trials as Topic / standards
Computer Simulation
Dose-Response Relationship, Drug
Drug Development / organization & administration*
Drug Development / standards
Drug Dosage Calculations
Drug Industry / organization & administration
Humans
Models, Biological
National Institute of Child Health and Human Development (U.S.) / organization & administration*
National Institute of Child Health and Human Development (U.S.) / standards
National Institute of Mental Health (U.S.) / organization & administration*
National Institute of Mental Health (U.S.) / standards
Pediatrics / organization & administration*
Pediatrics / standards
Prescription Drugs / administration & dosage*
Prescription Drugs / pharmacokinetics
United States
United States Food and Drug Administration / standards