Methods Used for Pediatric Dose Selection in Drug Development Programs Submitted to the US FDA 2012‐2020

Author:

Green Francis G.1,Park Kyunghun1,Burckart Gilbert J.1ORCID

Affiliation:

1. Office of Clinical Pharmacology, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference35 articles.

1. Scientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000‐2012;Sacks LV;JAMA,2014

2. Postmarketing drug dosage changes of 499 FDA‐approved new molecular entities, 1980‐1999;Cross J;Pharmacoepidemiol Drug Saf,2002

3. Pediatric ontogeny: moving from translational science to drug development;Burckart GJ;J Clin Pharmacol,2019

4. The revolution in pediatric drug development and drug use: therapeutic orphans no more;Burckart GJ;J Pediatr Pharmacol Ther,2020

5. Failed pediatric drug development trials;Momper JD;Clin Pharmacol Ther,2015

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