TOSSICOLOGIA
Academic Year 2026/2027 - Teacher: FILIPPO CARACIExpected Learning Outcomes
Knowledge and Understanding
The course aims to provide students with fundamental knowledge of:
a) The general principles of toxicology and the basic concepts of toxicokinetics and toxicodynamics.
b) The concepts underlying toxicity assessment and the methods used to investigate the toxic effects of drugs.
c) Drug interactions and the risk of adverse drug reactions.
d) The toxicological profile of drugs used in the treatment of major neuropsychiatric disorders, as well as antibacterial, antiviral, antifungal, anticoagulant, and antineoplastic drugs.
e) The mechanisms underlying dependence and abuse, and their pharmacological treatment.
Overall, the course aims to provide an in-depth understanding of general and special toxicology. The course includes specific lectures featuring simulations of real clinical cases, with the primary objective of providing students with essential knowledge of drug interactions and the possible occurrence of adverse drug reactions.
Applied Knowledge and Understanding
To understand the main topics in clinical psychopharmacology, including current theoretical, experimental, and practical developments in the field.
Autonomy of Judgment
The ability to formulate and support personal interpretations of issues related to the subject.
Communication Skills
The ability to use the basic terminology of the discipline. The ability to communicate with the various specialists involved in the drug discovery process, using appropriate toxicological terminology, while also being able to explain basic toxicology concepts clearly and accurately to non-specialists.
Learning Skills
To have acquired a body of knowledge useful for further study of the disciplines comprising the degree programme. The ability to independently expand and update one’s knowledge, including through the use of specialized literature and appropriate bibliographic resources.
Course Structure
The course will consist of lectures
Part of the teaching hours will be devoted to analysing the possible applications of preclinical toxicology tests in drug discovery processes. The course includes specific lectures featuring simulations of real clinical cases, the primary objective of which is to provide students with essential knowledge of drug interactions and the possible occurrence of adverse drug reactions.
Should the course be delivered in a blended or distance-learning format, the necessary changes may be introduced with respect to the arrangements described above in order to comply with the programme outlined in this syllabus.
According to the provisions of the RDA, Article 12 – University Educational Credits (CFU), within the standard workload of 25 hours of total student commitment corresponding to one credit, the following activities may be included:
a) 7 hours devoted to lectures or equivalent teaching activities, with the remaining hours dedicated to individual study;
b) no fewer than 12 and no more than 15 hours devoted to classroom exercises or equivalent supervised activities (laboratory work), with the remaining hours dedicated to study and individual review.
Students may use AI as a study-support tool, in compliance with the applicable legislation, including copyright law and the regulations governing the use of intellectual works, as described in section 5.1 of the guidelines:
Required Prerequisites
Attendance of Lessons
Detailed Course Content
General principles of toxicology and classification of toxic effects . Adverse Drug Reactions in Clinical Practice. Factors That Contribute to ADRs. Over Prescribing and Drug Interactions: the role of pharmacogenetics. Allergic Reactions. Idiosyncratic Reactions. Immediate vs. Delayed Hypersensitivity Reactions. Medication warnings and Pharmacovigilance. Clinical trials design and ADRs. Teratogenesis.
Predictive toxicology: risk evaluation, LOEL, LOAEL, NOEL, NOAEL, NEL, Safety and ADI. Dose-Response. Types of Dose-Response Relationships. Concentration-Effect and Presence at the Receptor Site. Criteria for Measurement. LD50 (Lethal Dose 50%). Definition. ED50 (Effective Dose 50%), and TI (Therapeutic Index).
Role of preclinical toxicology in drug discovery processes: methods and assays. Molecular and cellular mechanisms of toxicity. General mechanisms of cellular damage. Free radicals. Molecular mechanisms of genotoxicity. Mutagenicity. Carcinogenicity.
Toxicological profile of therapeutic agents currently used for the treatment of neurological and psychiatric disorders (antidepressants, esketamine, psylocibine, benzodiazepines, antipsychotics, antiparkinsonian agents, antidementia drugs analgesic drugs). Toxicological profile of antibiotics, antiviral agents (with a focus on anti-HIV ed anti-HBV ed anti-HCV drugs), antifungal agents, anticoagulants and antineoplastic drugs.
Neurobiological basis and pharmacological treatment of drug abuse. Tolerance and dependence. general principles. Classification and toxicology of drugs of abuse.
Textbook Information
1- Rossi, Cuomo, Riccardi – Farmacologia (Principi di base ed applicazioni terapeutiche)
2- Cantelli Forti et al., - Tossicologia cellulare e molecolare. Ed UTET
Course Planning
| Subjects | Text References | |
|---|---|---|
| 1 | Principi generali di tossicologia. Meccanismi molecolari e cellulari di tossicità. Tossicologia dei chemioterapici. | 1 |
| 2 | Aree della tossicologia. Classificazione degli effetti tossici. Reazioni allergiche,idiosincrasia, tossicità immediata e ritardata, reversibile, irreversibile, locale, sistemica. | 1 |
| 3 | Interazioni tra farmaci. Variabilità della risposta tossicologica: aspetti farmacocinetici e farmacodinamici | 1-2 and synthetic handouts provided by the lecturer |
| 4 | Tossicologia predittiva. Valutazione del rischio. Soglia di tossicità, effetti privi di soglia. LOEL, LOAEL, NOEL, NOAEL. | 1-2 and synthetic handouts provided by the lecturer |
| 5 | Relazione dose-effetto. Curve dose-risposta. Margine di sicurezza, ADI. Principi e definizioni della farmacovigilanza. | 1-2 and synthetic handouts provided by the lecturer |
| 6 | Meccanismi generali di danno cellulare. Radicali liberi. Meccanismi di genotossicitá, mutagenesi, cancerogenesi e teratogenesi | 1-2 and synthetic handouts provided by the lecturer |
| 7 | Profilo tossicologico dei farmaci utilizzati per il trattamento delle patologie del SNC e delle patologie cardiovascolari, profilo tossicologico dei farmaci antibatterici, antivirali, antimicotici ed antineoplastici | 1-2 and synthetic handouts provided by the lecturer |
| 8 | Tossicologia delle sostanze d’abuso. Meccanismi delle tossicodipendenze.. Classificazione delle sostanze d'abuso. Potenziale tossicomanigeno. | 1-2 and synthetic handouts provided by the lecturer |
Learning Assessment
Learning Assessment Procedures
Oral Exam
Learning assessment takes place exclusively through a final exam, which verifies the acquisition of the expected knowledge and skills through an oral examination, with the possibility of student-chosen in-depth topics.
The evaluation criteria are listed below: a) relevance of the answers to the questions formulated; b) quality of the content; c) ability to connect with other topics covered in the syllabus; d) ability to provide examples; e) command of technical terminology; f) overall expressive capacity of the student.
CInAP support will be required in presence of specific teaching activities related to specific needs
link Exams CTF: http://www.dsf.unict.it/corsi/lm-13_ctf/calendario-esami
Examples of frequently asked questions and / or exercises
Allergic reactions Idiosyncrasy Immediate and delayed reversible, irreversible, local, systemic toxicity Interactions between drugs and aspects of pharmacogenetics. Teratogenesis Adverse reactions and principles and definitions of pharmacovigilance. LOEL LOAEL NOEL, NOAEL Preclinical Toxicology in Drug Development. Molecular and cellular mechanisms of toxicity.
Esketamine, psylocibine, anticoagulants
General mechanisms of cell damage. Free radicals. Mechanisms of genotoxicity, mutagenesis Therapeutic uses and toxicity from antineoplastic drugs Therapeutic uses and antimicrobial drug toxicity Pharmacokinetic interactions Pharmacodynamic interactions Neurobiological basis of the neurotoxic action of drugs of abuse Cellular and molecular mechanisms of toxicity Adverse reactions related to CYP450 inhibition Toxicity profile of tricyclic antidepressants Adverse reactions of antivirals Adverse reactions of anti-HCV drugs