Study-unit TOXICOLOGY - PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
| Course name | Pharmacy |
|---|---|
| Study-unit Code | A000543 |
| Location | PERUGIA |
| Curriculum | Comune a tutti i curricula |
| CFU | 10 |
| Course Regulation | Coorte 2020 |
| Supplied | 2024/25 |
| Supplied other course regulation | |
| Type of study-unit | Obbligatorio (Required) |
| Type of learning activities | Attività formativa integrata |
| Partition |
PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
| Code | A000542 |
|---|---|
| Location | PERUGIA |
| CFU | 5 |
| Lecturer | Claudia Volpi |
| Lecturers |
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| Hours |
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| Learning activities | Affine/integrativa |
| Area | Attività formative affini o integrative |
| Sector | BIO/14 |
| Type of study-unit | Obbligatorio (Required) |
| Language of instruction | Italian |
| Contents | Pre- and post-marketing drug development and surveillance. Analysis of Pharmacovigilance procedures in Italy, EU and USA. |
| Reference texts | Notes from lessons and slides in Unistudium Rossi, Cuomo, Riccardi- Farmacologia- V edizione- Ed. Minerva Medica |
| Educational objectives | Knowledge of the main steps leading to the development, the clinical study and the post-marketing surveillance of the drugs. Pharmacovigilance procedures in theory and practice |
| Prerequisites | General pharmacology and pharmacotherapy; fundamentals of pharmaceutical legislation |
| Teaching methods | Theorical lessons |
| Other information | Attendance suggested |
| Learning verification modality | The acquisition of all the described skills will be verified by means of an oral examination. Oral test consists on an interview of about 30 minutes aiming to ascertain the knowledge and understanding level acquired by the student on theoretical contents as indicated on the program. |
| Extended program | Pre- and post-marketing drug testing; history and definition of pharmacovigilance; ADR mechanisms; active and passive pharmacovigilance; spontaneous reporting and reporting form; national legislation. Vaccinovigilance, Cosmetovigilance |
| Obiettivi Agenda 2030 per lo sviluppo sostenibile | Yes, goal 3 |
TOXICOLOGY
| Code | 50125702 |
|---|---|
| Location | PERUGIA |
| CFU | 5 |
| Lecturer | Marco Gargaro |
| Lecturers |
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| Hours |
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| Learning activities | Caratterizzante |
| Area | Discipline biologiche e farmacologiche |
| Sector | BIO/14 |
| Type of study-unit | Obbligatorio (Required) |
| Language of instruction | Italian |
| Contents | The course aims to show the negative aspects related to exposure to xenobiotics and to the administration of drugs in particular. The first part of the course describes the basic principles of toxicology and preclinical toxicology studies, also evaluating the state of the art of new alternative methodologies to the use of animals. In the second clinical part, particular emphasis will be given to the description of ADRs, in particular to the interaction between drugs. During practical exercises, the necessary knowledge will be provided to perform in vitro toxicological tests and carcinogenicity assays at both cellular and molecular levels. |
| Reference texts | Casarett & Doull Elementi di Tossicologia A cura di Patrizia Hrelia, Giorgio Cantelli Forti Casa Editrice Ambrosiana. e Tossicologia. Principi e applicazione all'uso dei farmaci e dei prodotti della salute. Piera Ghi, Massimo Allegrucci, Antonello Di Paolo. Minerva Medica, 2009. |
| Educational objectives | To transfer to future pharmacists the basics of toxicological knowledge necessary for the proper use and dispensing of drugs, herbal remedies, and related products. |
| Prerequisites | General Pharmacology and Pharmacotherapy exams have to be passed. |
| Teaching methods | Classroom lectures on all topics described in the program held by the instructor. Student participation is encouraged to identify any learning difficulties. Practical exercises. |
| Other information | Recommended frequency |
| Learning verification modality | The acquisition of all the described skills will be verified by means of an oral examination. Oral test consists of an interview of about 20 minutes aiming to ascertain the knowledge and understanding level acquired by the student on theoretical and methodological contents as indicated on the program. Students with disabilities and/or DSA are invited to visit the page dedicated to the tools and measures envisaged and to agree in advance what is necessary with the teacher (https://www.unipg.it/disabilita-e -dsa). |
| Extended program | Principles of toxicology. Areas of toxicology, characteristics of exposure, risk assessment, types of adverse effects. Dose-response relationships, threshold and non-threshold effects, hormesis, essential nutrients. Animal experimentation and alternatives for determining the toxicity of a drug. Classification of toxic effects, dose-effect relationship. Cell damage mechanisms. Fundamental secondary and side effects of drugs. Factors that influence the toxic response: factors related to the toxic, the individual and the contact time. Acute, subacute, subchronic, chronic toxicity, mutagenesis, carcinogenesis. Medicines and pregnancy: how to manage therapy in pregnancy. Teratogenesis: stages of development, developmental genes, main teratogenic substances: thalidomide, DES and alcohol. Controlled clinical trials, meta-analyzes and evidence-based medicine. The placebo effect, the nocebo effect. Classification of ADRs, interactions between drugs, phytotherapeutic drugs and foods. QT prolongation: one of the most serious adverse drug reactions. Substances of abuse: characteristics of the different substances of abuse, transition from compulsive abuse to psychic addiction. Prescription opioid overdose. Practical lessons: Handling immortalized, primary, and organoid cell cultures. MTT toxicity testing. Identification of the minimum toxic dose. Ames test to determine drug carcinogenicity. Test for drug interaction evaluation using luciferase reporter systems. |
| Obiettivi Agenda 2030 per lo sviluppo sostenibile | Health and wellness |