Safety Assessment in Drug Discovery and Development

 

Course - Stockholm, Sweden

 

The course identifies the different steps of the entire process of drug discovery and development, and the critical role played by safety assessment in a drug project moving through that process. The students will discuss and practice the assessments needed during the discovery and development phases, as well as the post-marketing phase. The importance of a safety assessment during target identification is highlighted, and special emphasis is put on how to include and evaluate toxicologically relevant in silico, in vitro and in vivo methods into a drug project during the discovery phase. The regulatory requirements, covering both pre-clinical and clinical studies in the development phase, are explored, with the aim to enable the students to put animal and human data into a regulatory context. Translational safety assessment, which bridges the gap between animal and human studies, is a special focus area. New relevant methods (such as adverse outcome pathways and non-animal methods), enabling a predictive approach to the process, are introduced. The occurrence and importance of pharmaceuticals in the environment is discussed.

 

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