1. European Medicines Agency (1998) ICH Topic E8 General Considerations for Clinical Trials. Note for guidance on general considerations for clinical trials. EMEA/CPMP/ICH/291/95
2. Duff G (2006) Expert Scientific Group on Phase One Clinical Trials Final Report. Stationery Office, Norwich, UK
3. European Medicines Agency (1998) ICH Guideline S6 Pre-clinical Safety Evaluation of Biotechnology-Derived Products. EMEA/CPMP/ICH/302/95
4. European Medicines Agency (2000) ICH Guideline M3 (Rl) Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals. EMEA/CPMP/ICH/286/95
5. European Medicines Agency, Committee for Medicinal Products for Human Use (2007) Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products. EMEA/CHMP/SWP/28367/07