Data-Driven Assessment of the Association of Polymorphisms in 5-Fluorouracil Metabolism Genes with Outcome in Adjuvant Treatment of Colorectal Cancer

Author:

Sarac Sinan B.,Rasmussen Christian H.,Afzal Shoaib1,Thirstrup Steffen2,Jensen Søren A.3,Colding-Jørgensen Morten4,Poulsen Henrik E.,Mosekilde Erik5

Affiliation:

1. Department of Clinical Biochemistry; Herlev Hospital; Herlev; Denmark

2. Danish Medicines Agency; Copenhagen; Denmark

3. Department of Oncology; Herlev Hospital; Herlev; Denmark

4. Novo Nordisk A/S; Bagsvaerd; Denmark

5. Department of Physics; Technical University of Denmark; Lyngby; Denmark

Publisher

Wiley

Subject

Pharmacology,Toxicology,General Medicine

Reference45 articles.

1. The Council for International Organizations of Medical Sciences (CIOMS) Working CIOMS group IV - benefit-risk balance for marketed drugs: evaluating safety signals [online] http://www.cioms.ch/publications/g4-benefit-risk.pdf

2. US Food and Drug Administration (FDA) The future of drug safety - promoting and protecting the health of the public [online] http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM171627.pdf

3. Committee for Medicinal Products for Human Use (CHMP) Report of the CHMP working group on benefit-risk assessment models and methods http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf

4. Measuring Benefit and Balancing Risk: Strategies for the benefit-risk assessment of new medicines in a risk-averse environment Washington, DC, US: 19-20 June 2008 http://www.cmr.org

5. Strategies for Communicating Benefit-Risk to Decision Makers: Explaining Methods, Findings and Conclusions Through a Common Approach Washington, DC, US: 17-19 June 2009 http://www.cmr.org/workshops

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