Progress in Drug Development–Pediatric Dose Selection: Workshop Summary

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...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2021-06, Vol.61 (S1), p.S13-S21
Main Authors: Wang, Jian, den Anker, John N., Burckart, Gilbert J.
Format: Article
Language:English
Subjects:
allometry
Child
Clinical Trials as Topic - organization & administration
Clinical Trials as Topic - standards
Dose-Response Relationship, Drug
Drug development
Drug Development - organization & administration
Drug Development - standards
Drug Dosage Calculations
Drug dosages
Humans
Kidney Function Tests
Models, Biological
PBPK
Pediatrics
pediatrics (ped)
Pediatrics - organization & administration
Pediatrics - standards
Pharmacogenetics
Prescription Drugs - administration & dosage
special populations
United States
United States Food and Drug Administration
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Description
Summary: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.
ISSN:0091-2700
1552-4604
DOI:10.1002/jcph.1828