1. 1Food and Drug Administration. Center for drug evaluation and research: a guidance on estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078932.pdf. July 2005 (last accessed on 20 July 2009).
2. 2Expert Scientific Group on Phase I Clinical Trials (Duff, G., Chair). Final Report. The Stationary Office, Norwich, UK, 30th November 2006. ISBN-10 0 11 703722 2. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117?IdcService=GET_FILE&dID=136063&Rendition=Web (last accessed on 20 July 2009).
3. 3European Medicines Agency. European Medicines Agency: guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products. http://www.emea.europa.eu/pdfs/human/swp/2836707enfin.pdf. 1 September 2007 (last accessed on 20 July 2009)..
4. On the prediction of the human response: a recycled mechanistic PK/PD approach;Meno-Tetang;Basic Clin Pharmacol Tox,2005
5. On the anticipation of the human dose in first-in-man trials from preclinical and prior clinical information in early drug development;Lowe;Xenobiotica,2007