First-in-human clinical trials with vaccines—what regulators want-Reference-Cited by-同舟云学术

First-in-human clinical trials with vaccines—what regulators want

Published:2010-09 Issue:9 Volume:28 Page:910-916
ISSN:1087-0156
Container-title:Nature Biotechnology
language:en
Short-container-title:Nat Biotechnol

Author:

Goetz Karen B,Pfleiderer Michael,Schneider Christian K

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering,Molecular Medicine,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Link

http://www.nature.com/articles/nbt0910-910.pdf

Reference28 articles.

1. European Medicines Agency. Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products CHMP/SWP/28367/07 (EMA, London; 2007). < http://www.ema.europa.eu/pdfs/human/swp/2836707enfin.pdf >

2. US Food and Drug Administration (FDA). Guidance for Industry and Reviewers, Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers (FDA, Washington, DC; 2002). < http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm078932.pdf >

3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Guideline E8: General Considerations for Clinical Trials. (ICH, Geneva; 1997). < http://www.ich.org/LOB/media/MEDIA484.pdf >

4. European Medicines Agency (EMA). Note for Pre-clinical Pharmacological and Toxicological Testing of Vaccines CPMP/SWP/465/95. (EMA, London; 1997). < http://www.ema.europa.eu/pdfs/human/swp/046595en.pdf >

5. European Medicines Agency (EMA). Guideline on Clinical Evaluation of New Vaccines CHMP/VWP/164653/05. (EMA, London; 2006). < http://www.ema.europa.eu/pdfs/human/vwp/16465305enfin.pdf >

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