New pathway for qualification of novel methodologies in the European medicines agency-Reference-Cited by-同舟云学术

New pathway for qualification of novel methodologies in the European medicines agency

Published:2011-04-28 Issue:5-6 Volume:5 Page:248-255
ISSN:1862-8346
Container-title:PROTEOMICS - Clinical Applications
language:en
Short-container-title:Prot. Clin. Appl.

Author:

Manolis Efthymios,Vamvakas Spiros,Isaac Maria

Funder

European Medicines Agency

Publisher

Wiley

Subject

Clinical Biochemistry

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/prca.201000130/fullpdf

Reference17 articles.

1. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500004913.pdf

2. http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm

3. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004201.pdf

4. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002880.pdf

5. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency European;Regnstrom;J. Clin. Pharmacol.,2010

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