54744 - Drug Science

Academic Year 2021/2022

Learning outcomes

At the end of the course,the student has skills on the fundamental principles that govern the development of the drug. In particular, the student is able to: - plan projects for development of an innovative drug for a disease important for a global market- carry out a comparative evaluation between public spending and the potential benefits of treatment with drugs

Course contents

Development of a conventional drug

Tools, in vitro, in vivo and in silico systems

Preclinical development, drug discovery

Preclinical pharmacokinetics, from animal to man

Experimental models in preclinical studies

Safety pharmacology 

Safety preclinical studies

Asymmetry: non-genetic effects in preclinical development

Clinical trials (Phase I, II and III)

Clinical Research Associate

Registration dossier and leaflet

Marketing authorization procedures

Pharmacovigilance

 

Differences with Orphan drugs

Development of a Biological drug

 

Development of an Anticancer drug

 

Development of a Vaccine (the case of Covid 19)

Readings/Bibliography

Texts suggested: L.M. Fuccella, E. Perucca, C. Sirtori - Farmacologia clinica - Casa Editrice UTET, Torino , E. Hogdson - Tossicologia moderna - Casa Editrice EDISES, P. Dolara - Farmacologia e tossicologia sperimentale - Pitagora Editrice, Bologna. A. Wallace, A. Hayes - Principles and methods of toxicology - Raven Press, New York.

Teaching methods

The course is divided into lectures, seminars and discussion. Class attendance is not mandatory but strongly recommended for a better learning of the subject. The exercises in the laboratory will be carried out by dividing the students into various groups (from 10 to 15), each of which will be dedicated to the same period of exercise. The exercises will be carried out at the end of the lectures and are mandatory, at least 2/3.

Assessment methods

The exam is a written test of 2 hours (or an oral on the basis of the evolution of the health emergency) during which is not allowed the use of books, notes and electronic media and a subsequent short oral examination when necessary. The test aims to verify the knowledge of the subject matured by the student who, together with his critical capacity, will determine positive evaluations. Lack of orientation in the topics covered during the course, training gaps and inappropriate language, including purely grammatical errors, will result in negative evaluations. The vote obtained will be used, in agreement with the Hygiene teaching, for the calculation of the weighted average which will constitute the final mark of the Integrated Course.

Teaching tools

PC computer projector
Distribution of the material projected during the lesson

Office hours

See the website of Moreno Paolini