The course aims at acquiring the theoretical and methodological principles underlying toxicology. The course provides the most important knowledge on the toxic effects of xenobiotics in general but focuses with greater emphasis on the toxicity of the main classes of drugs whose knowledge is essential for the practice of the pharmacist profession.

General principles of toxicology. Xenobiotics, toxic agents and toxins; dose, exposure. Characteristics of the exposure to toxic agents. Spectrum of the undesired effects; immediate versus delayed toxicity; local versus systemic toxicity; reversible versus irreversible toxic effects; allergic and idiosyncratic reactions. Basic principles of chemically-induced mutagenesis and carcinogenesis. Direct-acting versus indirect carcinogens. Developmental and reproductive toxicology. Interaction of chemicals; antidotes; selective toxicity. Dose-response relationship in toxicology: individual and graded dose-response relationship for toxicant with or without threshold; hormesis. Lethal dose 50 (LD50), therapeutic index, margin of safety and exposure, chronicity index, lethal time 50 (LT50).
Toxicokinetics and toxicogenetics. Disposition of toxicant: basic concepts; factors involved in the biotransformation and disposition of xenobiotics. Genetic individuality and toxic reactions, pharmacogenetics and adverse reactions to drugs and other xenobiotics.
Toxicology in drug development. Preclinical animal studies and international harmonization. Acute and repeated-dose studies (subacute, subchronic, and chronic testing). Developmental and reproductive toxicology. New technologies in pre-clinical toxicology. Toxicology in clinical studies
Mechanisms of toxicity. Processes that can change the concentration of the terminal toxic species to the target. Mechanisms and consequences of the cellular damage. Adaptive responses and toxicity resulting from tissue-specific alterations in cell growth and differentiation.
Target organ toxicity. Features, pathogenic mechanisms, types of toxic effects and main toxic agents for the nervous system, liver, kidney, heart, and vessels, respiratory system, endocrine system, immune system, skin
Toxicity in pregnancy and during postnatal development. General principles of drug-induced teratogenesis and relation with the dose and exposure period. Mechanisms of teratogenesis. Methods to determine the safety of drugs during pregnancy. General principles of pharmacotherapy in pregnancy and during lactation
Drug toxicity. General principles and interactions. Classification of adverse drug reactions (ADR). ADR induced by drug interactions. The prescription cascade. Other problems related to the use of drugs: therapeutic ineffectiveness, addiction, and abuse, overdose and poisoning, indirect adverse effects.

Pharmacovigilance and phytovigilance. Pharmacovigilance system. Pharmacovigilance methods. Pharmacovigilance legislation. Phytovigilance.

Risk assessment. Hazard Identification: structure-activity relationship, in vitro tests and short-medium-long term animal tests; epidemiological data and on the mechanisms of action. Evaluation of the dose-response relationship: the toxic effects with and without thresholds. Risk perception, characterization, management, and communication.
Toxic effects of drugs and substances used in the diagnostic field. Analgesics and anti-inflammatory, cardiovascular, hypoglycemic drugs. Drugs acting on the nervous system, the gastrointestinal system and the respiratory system. Chemotherapeutic and biotechnological drugs. Herbal products. Cosmetics. Toxicity of the contrast media.
Drugs of abuse. Neurobiology of addiction and the main drugs of abuse.
Clinical toxicology. Acute poisoning: decontamination, symptomatic therapy, late manifestations, antidotes. Examples of poisoning: psychiatric drugs, antipyretics and NSAIDs, oral hypoglycemic agents, drugs of abuse, environmental agents, food poisoning
Environmental and Occupational Toxicology. Pesticides and other environmental contaminants.

General Pathology, Pharmacology and Pharmacognosy

Knowledge and understanding

• Knowledge of the theoretical and methodological principles underlying toxicology
• Ability to focus on issues related to the risk associated with exposure to xenobiotics in general and to drugs in particular.

Applied knowledge and understanding

• Know and understand the importance of in vitro and in vivo testing to identify and characterize toxicity or potential adverse reactions from xenobiotics and drugs.
• Know the main mechanisms of cell and organ toxicity
• Know the susceptibility factors to xenobiotics
• Know the principles underlying the risk assessment associated with exposure to potentially toxic substances and understand their potential limitations
• Know the main toxicological problems related to the use of drugs
• Know the main toxicological problems related to the substances of abuse
• Acquire the ability to monitor drug safety and provide adequate information for the correct use of drugs.
• Know the pharmacist's responsibilities regarding pharmacovigilance.
• Know the main toxicological problems related to the use of pesticides and other commonly used chemical agents.
• Acquire the ability to consult the main toxicological and pharmacovigilance databases for a continuous updating of the pharmacist's profession.

Making judgments

• Ability to read and interpret the toxicological results coming from scientific literature and from non-professional contexts.

Communication skills

• Knowing how to communicate with appropriate language the main toxicological problems faced during the teaching course.

Learning skills

• Ability to analyze and critically evaluate experimental and epidemiological research conducted in the toxicological field.

The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it

There are no support activities planned

Teaching

frontal lessons

Attendance

Basic knowledge of physiology, pathology, pharmacology and pharmacognosy

Class attendance is not mandatory but is strongly recommended on a regular basis to foster both classroom interaction and the acquisition of knowledge and skills.

Course books

TOSSICOLOGIA GENERALE E APPLICATA AI FARMACI
Balduini W., Costa Lucio G.
Editore: EDRA
ISBN: 978-88-214-3801-1

Alternative text in English that can be consulted:

Casarett and Doull, TOXICOLOGY The basic science of poisons

Author: Curtis D. Klaassen

Editor: McGraw-Hill

Assessment

The expected learning outcomes will be evaluated through a written test that includes 10 questions, 7 of which with multiple answers and 3 open on the topics covered during the lessons. The time available to answer the proposed questions is an hour and a half. The written test is followed by an oral exam the topics of the written test. The aim is to ascertain whether the student has acquired the basic concepts of toxicology described in the section on Learning Outcomes (Dublin Descriptors). The evaluation criteria are: the mastery of knowledge, the level of articulation of the answers, the level of mastery in the application of toxicological knowledge. The final grade, expressed in thirtieths, will be based on the evaluation of the answers of the written test and the oral examination.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.

Teaching

Non-attending students are invited to consult the reference texts indicated in the "Course books" section and the teaching material uploaded on Moodle (lesson slides and other teaching material).

Attendance

Basic knowledge of physiology, pathology, pharmacology and pharmacognosy

Course books

TOSSICOLOGIA GENERALE E APPLICATA AI FARMACI
Balduini W., Costa Lucio G.
Editore: EDRA
ISBN: 978-88-214-3801-1

Alternative text in English that can be consulted:

Casarett and Doull, TOXICOLOGY The basic science of poisons

Author: Curtis D. Klaassen

Editor: McGraw-Hill

Assessment

The expected learning outcomes will be evaluated through a written test that includes 10 questions, 7 of which with multiple answers and 3 open on the topics covered during the lessons. The time available to answer the proposed questions is an hour and a half. The written test is followed by an oral exam the topics of the written test. The aim is to ascertain whether the student has acquired the basic concepts of toxicology described in the section on Learning Outcomes (Dublin Descriptors). The evaluation criteria are: the mastery of knowledge, the level of articulation of the answers, the level of mastery in the application of toxicological knowledge. The final grade, expressed in thirtieths, will be based on the evaluation of the answers of the written test and the oral examination.

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.