20410823 - TOXICOLOGY AND PHARMACOVIGILANCE

The course aims to provide the student with fundamental knowledge on the basic principles of toxicology and pharmacovigilance. In particular, toxicological aspects deriving from the voluntary use or from the involuntary exposure of the human body to various toxic substances and/or drugs will be analysed. Furthermore, the theoretical-practical bases of pharmacovigilance will be provided. The knowledge acquired by the student will be useful in his professional practice, both in pharmacy and in research laboratories, as well as in development, production and control departments of pharmaceutical, cosmetic and food products, allowing him to predict and prevent the toxicity deriving from environmental contaminants and from both the correct and improper use of medicines.

Canali

teacher profile | teaching materials

Programme

General principles
Areas of study and specialization in toxicology; Classification of toxic agents; Definition of unwanted effects induced by a xenobiotic; Significance of local and systemic toxicity; Interaction between multiple xenobiotics and toxic responses; Selectivity of the toxic effect; Exposure characteristics (dose, duration, frequency); dose-effect relationship; therapeutic index; safety margin; NOAEL, LOAEL, DL50; Toxicological studies; Mechanisms of interference of xenobiotics with physiological processes; Concepts and mechanisms underlying the processes of absorption, biotransformation, distribution and excretion of a xenobiotic; Risk and Toxicity: meaning and consequences; Evaluation and extrapolation of experimental toxicological data to humans.
Organ and system toxicology
Liver, renal, cardiovascular, skin and CNS toxicity.
Developmental toxicology
Principles of developmental toxicology. Critical periods of susceptibility and risk assessment. Pathogenetic mechanisms of developmental toxicity. Toxicokinetics in pregnancy. Toxicity to the mother and effects on embryo-foetal development (ethanol, methylmercury, lead, etc.).
Food toxicology
Bacterial toxins; mycotoxins; pesticides; additives; animal and plant toxins. Quality control issues (contamination, adulteration, adulteration)
Substances of abuse
Toxicity, abuse, dependence, withdrawal from: stimulants, depressants, psychedelic-hallucinogens. Smart drugs
Toxic effects of pesticides, metals, solvents
Clinical toxicology
General antidotism. Poisonings from: acids, alkalis, carbon monoxide, sulfur dioxide, nitrogen oxides, ozone, paracetamol, amphetamines, anticholinergics, cyanide, digitalis, ethanol, hydrocarbons, insecticides (chlorinated, organophosphorus and carbamate, botanical), herbicides, polychlorinated biphenyls, iron, mercury, opiates, phenothiazines, salicylates, hypnotics and sedatives, tricyclic antidepressants. Toxicity of over-the-counter products.
Farmacovigilanza

Core Documentation

Casarett & Doull’s Toxicology: The Basic Science of Poisons, 9th edition
Power-point files of the lessons will be provided

To get an appointment with the Professor, email to: viviana.trezza@uniroma3.it


Reference Bibliography

scientific articles will be provided on the topics addressed in the classroom

Type of delivery of the course

Class lectures

Attendance

Attendance is compulsory

Type of evaluation

Two intercourse written assessments will be made, consisting of open questions and multiple-choice questions. The evaluation of each test will be in 30/30. Students who will get a score of at least 18 in each test will pass the exam, with a score corresponding to the average score of the two tests . Alternatively, students may also decide to have a single oral exam on the entire program of the course, with an overall evaluation in 30/30.