Preclinical drug development

• explain fundamental aspects of preclinical drug development.
• describe requirements for entering into clinical trials.
• explain the principles of selected cases of pharmacological drug screening and testing.
• describe the importance of early toxicity testing and the overall requirements for preclinical toxicological testing.
• demonstrate general knowledge on dissolution and absorption testing of drug candidates.
• explain the importance and principles of animal models for testing drug candidates.
• analyze and present a scientific paper related to preclinical drug development.
• synthesize a brief report (in teams) about a specific drug development challenges that demonstrates the above learning objectives.
• act as opponent at presentations by other students by giving constructive feedback to the scientic presentation.

Drug development is a complex process requiring disciplines ranging from early target identification and validation through safety and efficacy testing to market launch. This course will provide the students with an understanding of the most basic and important aspects of this process with a strong focus on preclinical drug development. Emphasis is put on solubility/dissolution, cell studies, toxicology testing and animal studies of drug candidates. There will also be lectures on pharmacology screening, clinical studies and on translational medicine etc. The course will cover development of small molecules as well as biopharmaceuticals and create an overview of the entire preclinical drug development phase. Several lectures are from experienced experts from the pharmaceutical industry as Novo Nordisk, Lundbeck and LEO Pharma and will be covering ‘real-world’ challenges in drug development. The course will include interactive lectures, presentations by students as well as team work on specific drug development challenges. This work will be presented by each group who will also act as opponent for another group.

Lectures, team work, journal discussions, oral presentations. The load between lectures and team work is approximately 50:50.

Minimum: 10.

Please be aware that this course will only be held if the required minimum number of participants is met. You will be informed 8 days before the start of the course, whether the course will be held.