Frameworks for Evaluating Qualitative and Quantitative Information on Adverse Drug Events throughout Development through to Marketing

Author:

Nomura Kaori,Edwards Brian David

Publisher

InTech

Reference42 articles.

1. Pirmohamed M, Park K. Adverse drug reactions: Back to the future. British Journal of Clinical Pharmacology. 2003;55:486-492

2. Waller P. An Introduction to Pharmacovigilance. Chichester: John Wiley & Sons Ltd.; 2010. 3 p. DOI: 10.1002/9781444316766

3. Kerbrat A, Ferre JC, Fillatre P, et al. Acute neurologic disorder from an inhibitor of fatty acid amide hydrolase. The New England Journal of Medicine. 2016;375:1717-1725. DOI: 10.1056/NEJMoa1604221

4. International Conference on Harmonisation of the Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline E6 Guideline for Good Clinical Practice [Internet]. 1996. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf [Accessed: Feb 1, 2018]

5. Council for International Organizations of Medical Sciences. Report of CIOMS Working Group VII: The Development Safety Update Report (DSUR): Harmonizing the Format and Content for Periodic Safety Reporting During Clinical Trials. Geneva: Council for International Organizations of Medical Sciences; 2006

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