Preclinical Drug Development [MSBMM102]

Learning outcomes

Students will be able:

• to design an experimental study to identify therapeutic targets
• to identify lead compounds
• to characterize pharmacokinetic (PK) and pharmacodynamic (PD) properties of lead compounds
• to assess in vitro and in vivo toxicity of lead compounds
• to apply critical thinking and analytical skills to interpret data sets

Objectives

This course provides a comprehensive overview of preclinical drug development process. Each stage of the process is developed in-depth and presented according to the current EMA (European Medicines Agency) legislation.

Content

1. General Introduction: Drug Business- concepts & metrics
2. Identification of Drug Targets
3. Drug Discovery
4. Preclinical Drug Development
5. Pharmacokinetics
6. Pharmacodynamics
7. In vitro toxicology
8. In vivo toxicology
9. Reproductive and developmental toxicity

Exercises description

Practicals

1. Introduction : theory, how to write a good report, utilization of a bibliography management software, cell culture reminders, exercises, …
2. Genotoxicity : Ames test
3. Cytotoxicity: MTT assay – test of different compounds on cancerous cells, determination of the IC50.
4. Hepatotoxicity: steatosis evaluation after treatment