General and Molecular Pharmacology - RILEVAMENTO REAZIONI AVVERSE DA FARMACI (2011/2012)

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Course code
Academic sector
Language of instruction
Teaching is organised as follows:
Activity Credits Period Academic staff Timetable
Teoria 1 I semestre Roberto Leone
Laboratorio 1 I semestre Roberto Leone

Learning outcomes

General educational goals
Provide students with theoretical and practical knowledge in the field of structural biology, basic and clinical pharmacology, and toxicology, with particular reference to finalizing the development, design and characterization of drugs. Provide students with the main elements of knowledge on basic research and application in the field of drugs and more generally on the scope of biomedicine, with particular reference to the phases of drug development in the clinic setting.

Specific educational goals
At the end of the course the student should know: the processes of production and extraction of drugs; the main methods for the preparation of pharmaceutical formulations; the drug structure- activity relationship; the interactions between different receptors and pharmacological activity; the general principles of pharmacokinetics and the modifying factors; the relationship between pharmacokinetics and pharmacodynamics; the modifications of drugs pharmacodynamics and relationship with chemical structure; the phases of drug development and the main rules for the conduct of preclinical and clinical studies on drugs; the key elements that characterize the pharmaceutical market, with particular reference to the analysis of consumption of the same; the different classification of drugs for the purposes of analysis to be made; the general principles of toxicology; the main tests for toxicological analysis.
The student will be able: to determine the main pharmacokinetic parameters; to define the structure-activity relationship; to know the main and innovative method for the study and preparations of drugs; to define the difference between acute and chronic toxicology; to run the main toxicology lab tests; to use the main database on adverse drug reactions; to encode drugs and adverse reactions; to perform analysis of consumption of drugs using the defined daily doses; to define characteristic and distinctive elements of adverse drug reactions.


• Adverse Drug Reactions (Leone R., 1+1 CFU)
- Analysis of Italian pharmaceutical market. Prescribing and self-medication drugs
- Efficacy and safety evaluation of new drugs: the randomized clinical trial
- Pharmacoepidemiology and Pharmacovigilance
- Classification systems of drugs and adverse drug reactions

- Laboratory practice:
 Drugs and adverse drug reactions databases: data meaning
 Signal detection using the Italian Pharmacovigilance Database

Assessment methods and criteria

See the italian version