Università degli Studi di Urbino Carlo Bo / Portale Web di Ateneo


A.Y. Credits
2016/2017 8
Lecturer Email Office hours for students
Walter Balduini
Teaching in foreign languages
Course partially taught in a foreign language English Spanish
This course is taught partially in Italian and partially in a foreign language. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language.

Assigned to the Degree Course

Industrial Pharmacy (LM-13)
Date Time Classroom / Location

Learning Objectives

To provide the general concepts of toxicology and the most important knowledge on the toxic effects of the main classes of drugs and other chemicals


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.
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.
Target organ toxicity.
Features, pathogenic mechanisms, types of toxic effects and main toxic agents for: 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. Relation with the dose and the 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 the 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. Methods in pharmacovigilance. The monitoring system of the drugs and the legislation on pharmacovigilance and on phytovigilance.
Main 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

Bridging Courses

General Physiology, Hygiene and Pharmacology and Pharmacognosy/Chemotherapy

Learning Achievements (Dublin Descriptors)

Ability to focus on issues related to the risk for exposure to chemical agents. Understand the importance of in vitro and in vivo experiments to identify and characterize the toxicity or potential adverse reactions of drugs and other xenobiotics. To understand the main mechanisms of cell and organ toxicity. To know the factors that increase of susceptibility of individuals to xenobiotics and the principles of risk assessment. To know the main issues relating to the use of pesticides and other commonly used chemicals. To know the responsibility of pharmacists regarding pharmacovigilance. To acquire the ability to monitor the safety of drugs and to provide adequate information on their correct use. To know how to consult the main databases in the field of toxicology and pharmacovigilance.

Teaching Material

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

Teaching, Attendance, Course Books and Assessment


Frontal lessons

Course books

Balduini W., Costa Lucio G.
Editore: EDRA
ISBN: 978-88-214-3801-1
Casarett and Doull


Written exam followed by oral discussion (Italian, Spanish or English)

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.

« back Last update: 08/11/2016

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