Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development-Reference-Cited by-同舟云学术

Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development

Published:2013-07 Issue:4 Volume:47 Page:474-483
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Baird Lynn G.,Trusheim Mark R.,Eichler Hans-Georg,Berndt Ernst R.,Hirsch Gigi

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/10.1177/2168479013487355.pdf

Reference25 articles.

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3. Baciu A, Stratton K, Burke SP, eds. Institute of Medicine Report. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press; 2006.

4. European Medicines Agency. EMA roadmap to 2015: the EMA contribution to science, medicines, and health. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101373.pdf. Adopted December 16, 2011. Accessed October 03, 2012.

5. Eichler H-G, Pignatti F, Flamion B, Leufkens H, Breckenridge A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov. 2008;7:818–826.

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