Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders-Reference-Cited by-同舟云学术

Regulatory Considerations for Early Clinical Development of Drugs for Diabetes, Obesity, and Cardiometabolic Disorders

Published:2014-11-11 Issue: Volume: Page:283-304
ISSN:
Container-title:Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development
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Author:

Fleming G. Alexander

Publisher

Springer London

Link

http://link.springer.com/content/pdf/10.1007/978-1-4471-4920-0_12

Reference71 articles.

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3. Rahalkar H. Historical overview of pharmaceutical industry and drug regulatory affairs. Pharmaceut Reg Aff. 2012;S11:002.

4. ICH Topic E6 (R1) Guideline for Good Clinical Practice. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf . Accessed 19 Sept 2014.

5. FDA Advisory Committees. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/default.htm . Accessed 18 May 2014.

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