Non-Clinical Safety Assessment

Basic Goals (EMA)

• Identify pharmacological properties
• PD (mode of action)
• PK (metabolism)
• Comparative physiology (extrapolation of animal data to humans)

• Understand toxicological profile
• Establish a safe initial dose level of first human exposure
• Identify parameters for clinical monitoring of potential adverse effects
• Special toxicity (e.g. genotoxicity, carcinogenicity, reproduction toxicity)