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.