Non-Clinical-Safety Assessment -Toxicology

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)

 

Further down to:On the same level: