Clinical Pharmacology and Applied Biochemistry

The general objective of the course is to provide students with knowledge and understanding of:
- the clinical phases of development of biological and biotechnological drugs;
- the design and interpretation of observational and intervention studies;
- the use of biochemical, genetic, and cellular information to identify patients who may benefit the most from pharmacological treatment or who may potentially be more susceptible to side effects;
- the therapeutic monitoring and vigilance of biological and biotechnological drugs;
- some of the methodologies useful in clinical and research laboratories employing biochemical and enzymatic approaches for diagnostics and the development of drugs and biotechnological products.

By the end of the course, students will be able to critically evaluate:
- the quality and design of a clinical study of a biotechnological drug;
- the processes of identification and validation of the endpoints in a clinical study;
- the potential and limitations of the most well-known diagnostic methodologies using biochemical and enzymatic approaches.
Students will also gain knowledge on aspects related to:
- pharmacoepidemiology and pharmacogenomics;
- pharmacovigilance;
- the related operational roles in the field of clinical research of biotechnological drugs.
Students will obtain a set of biochemical and pharmacological knowledge useful for further personal study and deepening of this subject.