Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA-Reference-Cited by-同舟云学术

Primary Endpoints in Pediatric Efficacy Trials Submitted to the US FDA

Published:2018-04-17 Issue:7 Volume:58 Page:885-890
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Green Dionna J.¹,Burnham Janelle M.¹,Schuette Paul²,Liu Xiaomei I.³,Maas Brian M.⁴,Yao Lynne⁵,McCune Susan K.⁶,Chen Joseph⁷,van den Anker John N.⁴,Burckart Gilbert J.¹

Affiliation:

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

2. Office of Biostatistics; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

3. Children's National Medical Center; Washington DC USA

4. University of North Carolina Eshelman School of Pharmacy; Chapel Hill NC USA

5. Office of New Drugs; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

6. Office of Pediatric Therapeutics; Commissioner's Office; US Food and Drug Administration; Silver Spring MD USA

7. University of California San Diego; Skaggs School of Pharmacy; San Diego CA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference26 articles.

1. Pediatric information in drug product labeling;Sachs;JAMA,2012

2. Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy;Wharton;Pediatrics,2014

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

4. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products 1998

5. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012;Downing;JAMA,2014

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