Pediatric post-marketing safety systems in North America: assessment of the current status-Reference-Cited by-同舟云学术

Pediatric post-marketing safety systems in North America: assessment of the current status

Published:2015-06-22 Issue:8 Volume:24 Page:785-792
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

McMahon Ann W.¹,Wharton Gerold T.¹,Bonnel Renan¹,DeCelle Mary¹,Swank Kimberley²,Testoni Daniela³,Cope Judith U.¹,Smith Phillip Brian³,Wu Eileen²,Murphy Mary Dianne¹

Affiliation:

1. Office of Pediatric Therapeutics, Office of the Commissioner; US Food and Drug Administration; Silver Spring MD USA

2. Office of Pharmacovigilance and Epidemiology; US Food and Drug Administration; Silver Spring MD USA

3. Duke Clinical Research Institute; Duke School of Medicine; Durham NC USA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference31 articles.

1. Extrapolation of adult data and other data in pediatric drug-development programs;Dunne;Pediatrics,2011

2. Adverse Event Detection in Drug Development: Recommendations and Obligations Beyond Phase 3

3. http://www.fda.gov/ScienceResearch/SpecialTopics/PediatricTherapeuticsResearch/ucm189227.htm

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