323106 VU Safety testing and risk assessment in drug development - MPS5 (2018S)

The lecture will provide a basic understanding of toxicological evaluations of drugs and chemicals, and the processing of toxicity tests. The students will be confronted with internationally accepted standard and alternative methods for safety testings in accordance to Guidelines that are used by professionals in industry, academia, and government to uncover potential risks like carcinogenicity, genotoxicity, reprotoxicity, etc. Addtionally, this course provides a brief overview of the aspects of regulatory risk assessment practices most relevant to estimate levels of exposure that are unlikely to produce negative health-related consequences. Finally, the attendees should put the acquired knowledge in practice by working in small groups on relevant toxicological questions.