safescimet course 3.2 - Organ/Systems Toxicology

During drug development the evaluation of the toxicity potential of a new compound to the different organ systems plays a crucial role in drug safety concepts. This course will provide participants with a comprehensive overview of organ specific toxicity and familiarize them with fundamental toxicity mechanisms. Emphasis will be given to organ function, anatomical structures, physiological aspects and the site-specific toxicities of heart, immune system, renal system, liver and lung. Lectures will cover experimental design and statistics as well as include real case studies, regarding apical, pre-clinical and clinical endpoints in drug safety research. Participants will be able to identify critical points in drug development and recognize when and how specialists of the several fields involved (especially liver, kidney, cardiovascular) need to be involved in order to receive a multidisciplinary solution.

Key questions addressed by the course

• Physiology and function of the main systems
• Specific organ toxicity and their relevance for human safety
• Molecular and biochemical changes determining the departure from normal organ functions
• Reliability of clinical parameters for determining the level and severity of organ/system toxicity
• Human versus rodents organ specific interaction of drugs and other chemicals
• Statistical methods and experimental design of studies for the evaluation of organ toxicity