- Docente: Moreno Paolini
- Credits: 6
- SSD: BIO/14
- Language: Italian
- Moduli: Moreno Paolini (Modulo 1) Moreno Paolini (Modulo 2)
- Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2)
- Campus: Bologna
- Corso: Second cycle degree programme (LM) in Health Biology (cod. 8023)
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
Drug discovery
Preclinical development
Legislation on animal experiments
Accommodation and care of laboratory animals
Preclinical Pharmacokinetics: approaches and test
Test of toxicity, genotoxicity and carcinogenicity
Epigenetics and related issues
Risk analysis: risk assessment
clinical trial
Clinical Research Associate
Registration dossier and leaflet
Marketing authorization procedures
Pharmacoepidemiology: sources documentation drugs
pharmacoeconomics
Development of a biotechnology drug
Development of an anticancer drug
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
Lectures and discussion. The laboratories (compulsory for 2/3) will be carried out at the end of lectures by dividing the students into four groups (from 10 to 20 students), each of which will be devoted the same amount of time.
Assessment methods
The exam is a written test (3 hours) during which is not allowed the use of books, notes and electronic media and a subsequent short oral examination when necessary
Teaching tools
PC computer projector
Distribution of the material projected during the lesson
Office hours
See the website of Moreno Paolini