Course Programme

Outcome of Module 2: Non-clinical, pharmaceutical and early clinical development


  • Choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds.
  • Integration of non-clinical tests into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials).
  • Steps in the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds). 
  • Planning of clinical trial supplies for test substance and comparators (active and placebo). 
  • Overview of non-study requirements prior to First-into-Man studies.
  • Molecular and cellular basis of toxic reactions.
  • Principles and practical application of pharmacokinetics and toxicokinetics.
  • Early exploratory development in man.
  • Principles of clinical pharmacology and their application to clinical development.
  • Influence of genetic factors in drug development and drug response.