- Docente: Donatella Canistro
- Credits: 6
- SSD: BIO/14
- Language: Italian
- Teaching Mode: Traditional lectures
- Campus: Bologna
- Corso: Second cycle degree programme (LM) in Health Biology (cod. 5729)
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from Mar 28, 2025 to May 29, 2025
Learning outcomes
At the end of the course, the student has skills on the fundamental principles that govern drug development. In particular, the student will be able to: - plan projects for the development of an innovative drug, for an important pathology, for a global market; - perform a comparative assessment between public expenditure and potential benefits of drug treatments.
Course contents
A drug is born: research and development process
Preclinical experimentation, drug discovery
Tools: general information on in vitro, ex vivo, in vivo and in silico systems
Preclinical pharmacokinetics, from animal to man
Experimental models in preclinical
Safety pharmacology
"Security" studies
Clinical trial
Registration dossier and leaflet
Marketing authorization procedures
Pharmacovigilance
Examples of drug development (conventional, biological, anti-cancer)
Notes on some classes of drugs:
Drugs used in dyslipidemias
Antiobesity drugs
Anticoagulant drugs
Anti-gout medications
Thyroid and antithyroid drugs
Anti-diabetic drugs
Oral contraceptives
Sedative-hypnotic and antidepressant drugs
Antihypertensive drugs and used in heart failure
Drugs used for reflux and gastric ulcer
Drugs and intestinal motility
Drug interactions: pharmacokinetic and pharmacodynamic interactions
Effect of nutrition on the action of drugs: modification of absorption, metabolism and elimination of drugs by the diet; influence of drugs on nutrient absorption.
Effect of drugs on nutritional status: drugs that interfere with taste perception; drugs that modulate hunger and satiety; weight gain as a side effect of medications.
Practical support. Sources of documentation. Consultation databases and websites on clinical trials. Database and websites available for information and updates on the pharmacological and pharmacotherapeutic profile of drug interactions.
Readings/Bibliography
Farmacologia Generale e Clinica. B.G. Katzung, VII Ed. Italiana, Casa Editrice Piccin ~ Nuova.
Farmacologia e tossicologia sperimentale. P. Dolara. Pitagora Editrice, Bologna.
Elementi di Tossicologia. Casaret & Doull. Casa Editrice Ambrosiana, Milano, ed. 2013.
Teaching methods
Face-to face or virtual lectures in Italian.The course is divided into lectures, seminar activities and discussion.
Assessment methods
The exam consists in an oral face-to-face or virtual test (30 minutes). The test aims to verify the knowledge of the subject matured by the student who, together with his critical capacity, will determine positive evaluations. The lack of orientation within the topics covered during the course, training gaps and inappropriate language will result in negative evaluations. The mark 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
The educational material presented in class will be made available for the students in electronic format, on http://virtuale.unibo.it. Username and password are reserved for students enrolled at the University of Bologna.
Office hours
See the website of Donatella Canistro
SDGs

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.