Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012

Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012–2018

Published:2020-06-22 Issue:5 Volume:108 Page:1018-1025
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Tanaudommongkon Irin¹,John Miyagi Shogo²,Green Dionna J.³,Burnham Janelle M.¹,Anker John N.²,Park Kyunghun¹,Wu Johanna⁴,McCune Susan K.³,Yao Lynne⁵,Burckart Gilbert J.¹

Affiliation:

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

2. Division of Clinical Pharmacology Children’s National Hospital Washington DC USA

3. Office of Pediatric Therapeutics Office of the Commissioner US Food and Drug Administration Silver Spring Maryland USA

4. Western University of Health Sciences Pomona California USA

5. Division of Pediatric and Maternal Health Office of New Drugs Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1886

Reference31 articles.

1. Off-Label Use of Drugs in Children

2. Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act

3. Two decades of off-label prescribing in children: a literature review

4. Off-Label Use of Drugs and Adverse Drug Reactions in Pediatric Units: A Prospective, Multicenter Study

5. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks

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