Ethical and practical issues in phase 1 trials in healthy volunteers

Author:

Senn Stephen

Publisher

John Wiley & Sons, Ltd

Reference37 articles.

1. Cytokine storm in a phase 1 trial of the anti-CD28 monoclonal antibody TGN1412;Suntharalingam;New England Journal of Medicine,2006

2. The storm has cleared: lessons from the CD28 superagonist TGN1412 trial;Hunig;Review of Immunology,2012

3. CMPH 2007 Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf

4. Statistical issues in first-in-man studies;Working Party on Statistical Issues in First-in-Man Studies;Journal of the Royal Statistical Society, Series A,2007

5. ESG 2006 Expert Scientific Group on Phase One Clinical Trials Final Report HM Stationery Office http://webarchive.nationalarchives.gov.uk/+/dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_063117

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