54744 - Drug Science

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

Animal model, ethical and scientific limits

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)

Registration dossier and leaflet

Marketing authorization procedures

Pharmacovigilance

 

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, interactive activities and discussion. Class attendance is not mandatory but strongly recommended for a better learning of the subject. The course partecipates in the University's didactic experimentation project.  The lessons will take place following an innovative teaching approach that involves the integration of lectures with on line intective activities (compulsory) held by experts from pharmaceutical multinationals. In itinere didactic test will also be carried out with a grade that will average with the final one . Exercises in the laboratory (1 CFU) will be carried out by dividing the students into two main  groups (from 25 to 30), each of which will be dedicated to the same period of exercise. The exercises will be carried out at the end of the lectures.

As concerns the teaching methods of this course unit, all students (including all the international incoming exchange students, i.e. ERASMUS) must attend Module 1, 2 online [https://www.unibo.it/it/servizi-e-opportunita/salute-e-assistenza/salute-e-sicurezza/sicurezza-e-salute-nei-luoghi-di-studio-e-tirocinio], while Module 3 on health and safety is to be attended in class. Information about Module 3 attendance schedule is available on the website of your degree programme ("studiare"--"formazione obbligatoria su sicurezza e salute").

 

Assessment methods

The exam is a written test of 2 hours/oral 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 writing and 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
The material shown during the lesson, including tables, videos and publications,  is provided to students in electronic format

Office hours

See the website of Moreno Paolini