Course Unit Page
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Teacher Moreno Paolini
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Credits 6
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SSD BIO/14
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Teaching Mode Traditional lectures
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Language Italian
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Campus of Bologna
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Degree Programme Second cycle degree programme (LM) in Health Biology (cod. 9212)
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Course Timetable from Mar 01, 2022 to May 26, 2022
SDGs
This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.




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