Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned-Reference-Cited by-同舟云学术

Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned

Published:2018-03 Issue:2 Volume:52 Page:199-205
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Sun Haihao,Temeck Jean W.,Chambers Wiley,Perkins Ginger,Bonnel Renan,Murphy Dianne

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479017725558.pdf

Reference29 articles.

1. Sachs AN, Avant D, Lee CS, Rodriguez W, Murphy MD. Pediatric information in drug product labeling. JAMA. 2012;307:1914–1915.

2. Dunne J, Rodriguez WJ, Murphy MD, et al. Extrapolation of adult data and other data in pediatric drug-development programs. Pediatrics. 2011;128: e1242–e1249.

3. FDA. Specific requirements on content and format of labeling for human prescription drugs; revision of “pediatric use” subsection in the labeling; final rule. Fed Regist. 1994;59:64240. https://www.federalregister.gov/documents/1994/12/13/94-30238/specific-requirements-on-content-and-format-of-labeling-for-human-prescription-drugs-revision-of.

4. The Pediatric Research Equity Act 2007. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf.

5. Best Pharmaceuticals for Children Act 2007. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM049870.pdf.

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