Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development-Reference-Cited by-同舟云学术

Exposure Matching for Extrapolation of Efficacy in Pediatric Drug Development

Published:2016-10-06 Issue:11 Volume:56 Page:1326-1334
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Mulugeta Yeruk¹,Barrett Jeffrey S.²,Nelson Robert³,Eshete Abel Tilahun⁴,Mushtaq Alvina⁵,Yao Lynne⁶,Glasgow Nicole⁷,Mulberg Andrew E.⁸,Gonzalez Daniel⁹,Green Dionna¹,Florian Jeffry¹,Krudys Kevin¹,Seo Shirley¹,Kim Insook¹,Chilukuri Dakshina¹,Burckart Gilbert J.¹

Affiliation:

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

2. Division of Clinical Pharmacology & Therapeutics; Children's Hospital of Philadelphia; Philadelphia PA USA

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

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

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

6. Pediatric and Maternal Health Staff; Office of New Drugs; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

7. University of Maryland School of Pharmacy; Baltimore MD USA

8. Division of Gastroenterology and Inborn Errors Products; Office of New Drugs; Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring MD USA

9. Division of Pharmacotherapy and Experimental Therapeutics; UNC Eshelman School of Pharmacy; University of North Carolina; Chapel Hill NC USA

Funder

National Institute of Child Health and Human Development

Thrasher Research Fund

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference20 articles.

1. US Food and Drug Administration Draft Guidance for Industry: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425885.pdf

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

3. Pharmacometrics-based dose selection of levofloxacin as a treatment for postexposure inhalational anthrax in children;Li;Antimicrob Agents Chemother,2010

4. Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop;Berde;Pediatrics,2012

5. An overview of the pediatric medications for the symptomatic treatment of allergic rhinitis, cough, and cold;Fan;J Pharm Sci,2013

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