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METODOLOGIA CLINICA APPLICATA AGLI STUDI DI RICERCA
Module Farmacologia e aspetti regolatori della sperimentazione clinica

Academic Year 2023/2024 - Teacher: Mariangela CHISARI

Expected Learning Outcomes

Studying General Pharmacology, students will learn principles necessary to understand drug development phases and clinical studies

that lead to drug marketing and to pharmacovigilance. In addition, they will develop the basics of critical reasoning by 

in-depth study of scientific articles related to clinical trials.

Course Structure

Traditional classes. Students are invited to actively participate with questions and comments on discussed topics.

If the teaching is given in a mixed or remote mode, necessary changes may be introduced in order to fullfill all statements in the Syllabus.

Required Prerequisites

Basic knowledge in the following topics: Anatomy, Histology, Biochemistry, Physiology, Pathology, Microbiology

Attendance of Lessons

Mandatory attendance to classes, except for new instructions for contingent reasons

Detailed Course Content

General principles of pharmacology

Pharmacokinetics

Pharmacodynamics

Factors that influence the pharmacological response 

Interactions  and adverse drug reactions

Drug development

Clinical studies and regulatory aspects

Pharmacovigilance

Discussion about scientific data related to clinical studies

Drugs active on the gastrointestinal system

Anti-inflammatory drugs

Anticancer drugs

Textbook Information

Clark, Finkel, Rey, Le basi della Farmacologia, Zanichelli 

Rang - Dale: Farmacologia, Ed. Edra

Course Planning

 SubjectsText References
1General principles of pharmacologysee texbook tab
2Pharmacokineticssee texbook tab
3Pharmacodynamicssee texbook tab
4Factors that influence the pharmacological response see texbook tab
5Interactions and adverse drug reactionssee texbook tab
6Drug developmentsee texbook tab
7Clinical studies and regulatory aspectssee texbook tab
8Pharmacovigilancesee texbook tab
9Discussion about scientific data related to clinical studiesscientific artcles
10Drugs for the gastrointestinal systemsee texbook tab
11Anti-inflammatory drugssee texbook tab
12Anticancer drugssee texbook tab

Learning Assessment

Learning Assessment Procedures

Oral exam about topics listed in the program and discussed during classes. The final evaluation will be determined by appropriate use of the scientific language, the ability to explain what has been learned, as well as by the skills of critical thinking.

Examples of frequently asked questions and / or exercises

Concentration response-curve, drug half-life, steady-state drug concentration