TOSSICOLOGIA

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.

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.

1- Rossi, Cuomo, Riccardi – Farmacologia (Principi di base ed applicazioni terapeutiche)

2- Cantelli Forti et al., - Tossicologia cellulare e molecolare. Ed UTET

Oral Exam

Assessment of learning takes place exclusively through the final examination. The examination assesses whether students have acquired the expected knowledge and skills through an oral examination, with the possibility of discussing topics of the student’s choice in greater depth.

The final examination is assessed using equally weighted indicators, in accordance with the expected learning outcomes described above. The final grade therefore takes into account the following factors:

Quality of the knowledge, skills and competencies demonstrated

• Appropriateness, accuracy and relevance of knowledge
• Appropriateness, accuracy and relevance of skills
• Appropriateness, accuracy and relevance of competencies

Presentation

• Ability to express oneself clearly
• Appropriate use of subject-specific terminology
• Logical reasoning and coherence in connecting the material
• Ability to link different topics by identifying common ground and developing a coherent overall framework, with due attention to the structure, organization and logical connections of the presentation
• Ability to summarize, including through the use of the subject’s own symbols and the graphical representation of concepts and information, for example in the form of formulas, diagrams and equations

Interpersonal qualities

• Willingness to engage and interact with the instructor during the oral examination

Personal qualities

• Critical thinking
• Ability to assess one’s own performance
• Problem-solving skills
• Decision-making skills

Grading scale

The grade is expressed on a scale of 30, according to the following criteria.

Fail

• Knowledge and understanding of the subject: significant gaps and inaccuracies
• Ability to analyze and synthesize: negligible; frequent overgeneralizations
• Use of references: completely inappropriate

18–20

• Knowledge and understanding of the subject: very limited, with evident shortcomings
• Ability to analyze and synthesize: barely adequate
• Use of references: barely appropriate

21–23

• Knowledge and understanding of the subject: slightly above a pass level
• Ability to analyze and synthesize: fair analytical and synthesis skills; arguments are presented logically and coherently
• Use of references: standard references are used

24–26

• Knowledge and understanding of the subject: good
• Ability to analyze and synthesize: good analytical and synthesis skills; topics are presented coherently
• Use of references: standard references are used

27–29

• Knowledge and understanding of the subject: very good
• Ability to analyze and synthesize: considerable analytical and synthesis skills
• Use of references: topics have been studied in greater depth

30, with honors (cum laude)

• Knowledge and understanding of the subject: excellent
• Ability to analyze and synthesize: considerable analytical and synthesis skills
• Use of references: substantial further study

To ensure equal opportunities and comply with current legislation, students who need support may request an individual meeting to plan any compensatory and/or dispensatory measures, in accordance with the learning objectives and their specific needs. They may also contact the Department’s faculty liaison for CInAP (Centre for Active and Participatory Inclusion – Disability and Specific Learning Disorders Services), Professor Santina Chiechio.

Examination dates are published on the Degree Programme website: https://www.dsf.unict.it/it/corsi/lm-13_ctf/calendario-esami

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