Module 2: From Non-Clinical Testing to First-in-Humans

Prioritising areas of therapeutic interest and target product profile. Principles for target identification, understanding of combinatorial chemistry and drugability of new compounds. Exploring possible new drugs by means of preclinical safety and efficacy testing. The choice and the predictive value of animal testing for toxicity data as well as the principles of ADME, possibilities and opportunities of computer assisted modelling on the way to proof of concept. Procedures and databases for pharmacovigilance and pharmacoepidemiology surveillance. Pharmaceutical engineering and choice of formulation.

Key topics

  • Non-clinical testing for chemical and biological compounds
  • Development of chemical and biological compounds
  • Non-clinical testing requirements prior to First-in-Human studies
  • Molecular and cellular basis of toxicological reactions
  • Genetic factors in drug development and drug response
  • Early exploratory development in man
  • Clinical pharmacology and application to clinical development

Learning outcomes

At the end of this Module the student should be able to describe the:

  1. The value of non-clinical testing programmes and their integration into the overall drug development plan
  2. Steps in the pharmaceutical development of a drug substance
  3. Principles of clinical pharmacology and their application to clinical development
  4. Requirements, planning and regulations of non-clinical and First-in-Human studies