FDA Engages Collaborators to Address Nonclinical Data Challenges-Reference-Cited by-同舟云学术

FDA Engages Collaborators to Address Nonclinical Data Challenges

Published:2013-01 Issue:1 Volume:47 Page:41-45
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Kropp Timothy J.,Rosario Lilliam A.,DeHaven Susan,Houser William,Kramer Lou Ann,Nath Shree,Smyrnios Troy,Wally Jeremy L.

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/10.1177/0092861512466398.pdf

Reference16 articles.

1. National Research Council. Emerging Safety Science: Workshop Summary. Washington, DC:The National Academies Press; 2008.

2. Harvard Business Review. Harvard Business Review on Aligning Technology With Strategy. Boston, MA:Harvard Business Publishing, 2011.

3. Rosario LA, Kropp TJ, Wilson SE, Cooper CK. Join FDA/PhUSE Working Groups to help harness the power of computational science. Drug Information Journal. 2012;46:523–524.

4. PhUSE. FDA Working Groups. http://www.phusewiki.org/wiki/index.php?title=FDA_Working_Groups. Accessed November 30, 2012.

5. FDA. Study Data Standards for Submission to CDER. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm248635.htm. Accessed November 30, 2012.

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