Medicine
Volume 36, Issue 7 , Pages 369-376 , July 2008

Drug development and regulation

References 

  1. Expert Group on Phase One Clinical Trials. Final report. London: The Stationery Office; 2006;Available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_063117(accessed 18 March 2008)
  2. Medicines and Healthcare Products Regulatory Agency UK website. Available at: www.mhra.gov.uk (accessed 18 March 2008).
  3. International Conference on Harmonization . E6(R1): Good Clinical Practice: Consolidated Guideline. ICH; 1996;Available at: http://www.ich.org/(accessed 18 March 2008)
  4. European Medicines Evaluation Agency website. Available at: http://www.emea.europa.eu/ (accessed 18 March 2008).
  5. Department of Health and Medical Research Council guidance on compliance with provision of European Clinical Trials Directive. Available at: http://www.ct-toolkit.ac.uk/ (accessed 18 March 2008).

PII: S1357-3039(08)00116-3

doi: 10.1016/j.mpmed.2008.04.007

Medicine
Volume 36, Issue 7 , Pages 369-376 , July 2008