Key Principles of Pharmacology

5. Further Reading

• Guideline on Strategies to Identify and Mitigate Risks in First-in-Human Clinical Trials with investigational Medicinal Products Available at: Guideline on Strategies to Identify and Mitigate Risks for First-In-Human Clinical Trials with Investigational Medicinal Products (europa.eu)
  
  
• Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals: Available at: ICH M3 (R2): Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (europa.eu)
  
  
• Preclinical safety evaluation of biotechnology-derived pharmaceuticals: Available at: S6(R1) Step 5 Preclinical safety evaluation of biotechnology-derived pharmaceuticals (europa.eu)
  
  
• The Non-Clinical Evaluation of the Potential for delayed Ventricular Repolarisation (QT Interval Prolongation) by Human Pharmaceuticals: Available at: 05-20959.pdf (govinfo.gov)
  
  
• Safety pharmacology studies for human pharmaceuticals: Available at: S 7 A Safety Pharmacology Studies for Human Pharmaceuticals (europa.eu)
  
  
• Toxicokinetics: the assessment of systemic exposure in toxicology studies: Available at: S 3 A Toxicokinetics: A Guidance for Assessing Systemic Exposure in Toxicology Studies (europa.eu)
  
  
• Position paper on the non-clinical safety studies to support clinical trials with a single micro dose: Available at: M3(R2) Step 5 Non-clinical safety studies for conduct of human clinical trials for pharmaceuticals (europa.eu)
  
  
• Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers: Available at: Guidance for Industry (fda.gov)