Interim Analysis: What Regulatory Affairs Professionals Need to Know-Reference-Cited by-同舟云学术

Interim Analysis: What Regulatory Affairs Professionals Need to Know

Published:2010-11 Issue:6 Volume:44 Page:703-712
ISSN:0092-8615
Container-title:Drug Information Journal
language:en
Short-container-title:Drug Information J

Author:

Coutant David

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Link

http://link.springer.com/content/pdf/10.1177/009286151004400606.pdf

Reference23 articles.

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2. World Health Organization. Guidance: operational guidelines for the establishment and functioning of data and safety monitoring boards (version 05.1). 2005. http://www.who.int/tdrold/publications/publications/pdf/operat_guidelines.pdf (accessed November 6, 2009).

3. European Medicines Agency, Committee for Medicinal Products for Human Use. Guidance: guideline on data monitoring committees. July 27, 2005. EMEA/CHMP/EWP/5872/03, http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf (accessed November 9, 2009).

4. National Institutes of Health. NIH policy: policy for data and safety monitoring. June 10, 1998. http://grants.nih.gov/grants/guide/notice-files/not98-084.html (accessed November 9, 2009).

5. International Conference on Harmonization. ICH guideline for good clinical practice. E6 (R1). May 1996. http://www.ich.org/cache/compo/276-254-1.html (accessed March 31, 2010).