Clinical Pharmacology and Pharmacoepidemiology and Pharmacoeconomics

A.Y. 2024/2025

Max ECTS

Overall hours

SSD

BIO/14

Language

Italian

Included in the following degree programmes

Pharmaceutical Chemistry and Technology (Classe LM-13)-Enrolled from 2009/10 Academic Year Until 2020/21

Pharmaceutical Chemistry and Technology (Classe LM-13)-Enrolled from 2021/22 Until 2022/23 Academic Year

Learning objectives

The aim of the course is to present the students with the most important aspects of clinical and epidemiological evaluation of a drug. The main topics covered during the course will be the experimental, legislative, ethical, clinical, economical and pharmaco-epidemiological aspects of drug discovery and use.

Expected learning outcomes

At the end of the course, the student will be able to follow the entire development of a new active compound or pharmaceutical formulation, to understand how to design a clinical study needed for marketing the new drug, and how to evaluate the results of this study from the clinical, pharmacoeconomical and pharmacoepidemiological points of view.

Lesson period: Second semester

Lessons timetable

Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi

Exams calendar

Single course

This course can be attended as a single course.

Take a single course

Course syllabus and organization

Single session

Responsible

Bellosta Stefano

Lesson period

Second semester

Syllabus

Prerequisites for admission

Students are required to attend and pass the exam of Pharmacology and Pharmacotherapy before attending the present course.

Assessment methods and Criteria

Written exam covering all the topics of the course. Three open questions, 90 minutes.

Clinical pharmacology

Course syllabus

1. How a drug is born
2. How to study a drug
3. Preclinical phase: innovation and the discovery of new drugs
4. Tissue cultures in drug development
5. Use of animal models and alternatives in drug development
6. Clinical phases: I, II, III, IV
7. Clinical experimentation: characterization of the diverse phases of a clinical study
8. Clinical protocol: how it is made
9. Experimental design
10. Special patients: the elderly, the young, the obese, the nephropathic, the hepatopatic
11. Anti-cancer chemotherapy
12. Vaccines

Teaching methods

Oral lessons and use of PCs for database consultation.
If necessary, lessons will be via Teams.

Teaching Resources

All the slides presented at the course and the recording of the lessons will be published on the Ariel website.

Pharmacoepidemiology and Pharmacoeconomics

Course syllabus

1. Pharmacoeconomy
2. Pharmacoepidemiology
3. Meta-analysis
4. Pharmacoepigenomics
5. Pharmacogenomics
6. Pharmacovigilance
7. Appropriateness in prescribing
8. Generic drugs
9. How to search for medical info on the web and databases
10. The Contract Research Organization
11. Risk management.

Teaching methods

Oral lessons in normal classrooms.
If the health situation will require it (pandemic still ongoing), oral lessons via Microsoft Teams.

Teaching Resources

All the slides presented at the course and the recordings of the lessons will be published on the Ariel website.

Course structure

Clinical pharmacology

BIO/14 - PHARMACOLOGY - University credits: 4

Lessons: 32 hours

Professor: Bellosta Stefano

Shifts:

Turno

Professor: Bellosta Stefano