Progress in Drug Development-Pediatric Dose Selection: Workshop Summary

Jian Wang; John N van den Anker; Gilbert J Burckart

doi:10.1002/jcph.1828

Progress in Drug Development-Pediatric Dose Selection: Workshop Summary

J Clin Pharmacol. 2021 Jun:61 Suppl 1:S13-S21. doi: 10.1002/jcph.1828.

Authors

Jian Wang¹, John N van den Anker², Gilbert J Burckart³

Affiliations

¹ Office of Specialty Medicine, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
² Division of Clinical Pharmacology, Children's National Hospital, Washington, DC, USA.
³ Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

PMID: 34185909
DOI: 10.1002/jcph.1828

Abstract

The "Pediatric Dose Selection" workshop was held in October 2020 and sponsored by the U.S. Food and Drug Administration and the University of Maryland Center for Excellence in Regulatory Science and Innovation. A summary of the presentations in the context of pediatric drug development is summarized in this article.

Keywords: PBPK; allometry; drug development; pediatrics (ped); special populations.

MeSH terms

Child
Clinical Trials as Topic / organization & administration*
Clinical Trials as Topic / standards
Dose-Response Relationship, Drug
Drug Development / organization & administration*
Drug Development / standards
Drug Dosage Calculations
Humans
Kidney Function Tests
Models, Biological*
Pediatrics / organization & administration*
Pediatrics / standards
Pharmacogenetics
Prescription Drugs / administration & dosage*
United States
United States Food and Drug Administration

Substances

Prescription Drugs