Toxicology and Pharmacovigilance
A.Y. 2026/2027
Learning objectives
Toxicology, defined as the science of poisons, studies the adverse effects of exogenous agents (e.g. pesticides, food additives, drugs, environmental pollutants, etc.) on living beings, their mechanism action and the evaluation of their hazard and the identification of safe uses through risk assessment. Toxicology is a multidisciplinary science that uses the knowledge and techniques of most branches of biology, biochemistry, physiology and medicine, chemistry, math and physics.
The purpose of the course is to provide:
1. The bases for a correct characterization of the adverse effects of xenobiotics, defining methods and approaches used in the toxicological evaluation. Particular attention will be paid to drugs.
2. The characterization of the molecular mechanisms underlying the adverse effects.
3. Organ toxicity, trying to define the type of damage induced at the level of the individual organs and the substances involved.
4. The characterization of the toxic effects of different classes of chemicals, such as pesticides, metals, solvents, natural toxins.
5. The bases of pharmacovigilance.
The purpose of the course is to provide:
1. The bases for a correct characterization of the adverse effects of xenobiotics, defining methods and approaches used in the toxicological evaluation. Particular attention will be paid to drugs.
2. The characterization of the molecular mechanisms underlying the adverse effects.
3. Organ toxicity, trying to define the type of damage induced at the level of the individual organs and the substances involved.
4. The characterization of the toxic effects of different classes of chemicals, such as pesticides, metals, solvents, natural toxins.
5. The bases of pharmacovigilance.
Expected learning outcomes
Assessment of learning: oral exam, in which the learning of the topics covered, the ability of synthesis and connection will be evaluated. The student's ability to frame the problems of toxicological evaluation in the perspective of assessing human and environmental safety will be evaluated. The student will have to demonstrate that he/she has understood the key concepts and the main operational tools that characterize the safety assessment of xenobiotics. The exam will last up to 30 minutes and up to five questions will be asked about the program. The answer to each question will be assigned a score from 0-30 and the weighted average of the scores obtained in the single questions will represent the final mark.
Lesson period: Second semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course cannot be attended as a single course. Please check our list of single courses to find the ones available for enrolment.
Course syllabus and organization
Surname A-L
Responsible
Lesson period
Second semester
Course syllabus
The aim of the course is to provide:
1. The basis for a correct characterization of the adverse effects of xenobiotics, defining methods and approaches used in the toxicological evaluation.
2. The characterization of the molecular mechanisms underlying the adverse effects, with particular attention to drugs.
3. Organ toxicity, trying to define the type of damage induced at the level of the individual organs and the substances involved, with particular attention to drugs.
4. The characterization of the toxic effects of the different classes of chemicals, such as pesticides, metals, solvents, biotechnology products, ionizing radiation, natural toxins.
5. Introduction to Pharmacovigilance
In particular, the following topics will be presented in depth:
- elements of general toxicology
- absorption, distribution, metabolism and excretion
- mechanisms of cellular damage and repair systems
- genotoxicity and chemical carcinogenesis
- immunotoxicology
- hematotoxicity
- developmental and reproductive toxicity
- hepatotoxicity
- nephrotoxicity
- neurotoxicity
- gastrointestinal toxicity
- cardiovascular toxicity
- pulmonary toxicity
- skin toxicity
- ocular toxicity
- drug toxicity
- drug of abuse toxicity
- endocrine disruptors
- metal toxicity
- solvent toxicity
- pesticide toxicity
- food toxicology
- toxicology of biotechnological products
- toxicology of nanomaterials
- natural toxins
- radiation ionizing
- outline of occupational toxicology
- outline of ecotoxicology and environmental fate
- risk assessment
- European agencies
- new methodological approaches in toxicology
- pharmacovigilance and phytovigilance
- pharmaco-utilization and analysis of administrative databases
Seminars by experts in specific field of toxicology are also provided.
1. The basis for a correct characterization of the adverse effects of xenobiotics, defining methods and approaches used in the toxicological evaluation.
2. The characterization of the molecular mechanisms underlying the adverse effects, with particular attention to drugs.
3. Organ toxicity, trying to define the type of damage induced at the level of the individual organs and the substances involved, with particular attention to drugs.
4. The characterization of the toxic effects of the different classes of chemicals, such as pesticides, metals, solvents, biotechnology products, ionizing radiation, natural toxins.
5. Introduction to Pharmacovigilance
In particular, the following topics will be presented in depth:
- elements of general toxicology
- absorption, distribution, metabolism and excretion
- mechanisms of cellular damage and repair systems
- genotoxicity and chemical carcinogenesis
- immunotoxicology
- hematotoxicity
- developmental and reproductive toxicity
- hepatotoxicity
- nephrotoxicity
- neurotoxicity
- gastrointestinal toxicity
- cardiovascular toxicity
- pulmonary toxicity
- skin toxicity
- ocular toxicity
- drug toxicity
- drug of abuse toxicity
- endocrine disruptors
- metal toxicity
- solvent toxicity
- pesticide toxicity
- food toxicology
- toxicology of biotechnological products
- toxicology of nanomaterials
- natural toxins
- radiation ionizing
- outline of occupational toxicology
- outline of ecotoxicology and environmental fate
- risk assessment
- European agencies
- new methodological approaches in toxicology
- pharmacovigilance and phytovigilance
- pharmaco-utilization and analysis of administrative databases
Seminars by experts in specific field of toxicology are also provided.
Prerequisites for admission
A solid understanding of the fundamental concepts of Pharmacology and Pharmacotherapy, as covered in the corresponding course, is essential for the effective comprehension of the subjects addressed in this module. In addition, toxicology is a multidisciplinary science, which uses knowledge and techniques from most branches of biology, biochemistry, physiology and medicine, chemistry, mathematics and physics. A minimum knowledge of these subjects is necessary to be able to follow the course.
Teaching methods
Frontal teaching with recommended frequency.
Teaching Resources
All lecture materials, including slides and additional resources used during in-person classes, are available for download on the MyAriel platform. The recommended textbooks, for further study, in addition to the materials provided by the lecturer, are:
- Galli, Corsini, Marinovich. Tossicologia, Ed. Piccin
- Casarett & Doull. Elements of toxicology of John B. III Watkins, Curtis D. Klaassen. Ed. CEA
- Galli, Corsini, Marinovich. Tossicologia, Ed. Piccin
- Casarett & Doull. Elements of toxicology of John B. III Watkins, Curtis D. Klaassen. Ed. CEA
Assessment methods and Criteria
Assessment of learning: oral exam, in which the learning of the topics covered, the ability of synthesis and connection will be evaluated. The grade is expressed on a scale of thirty; a minimum score of 18/30 is required to pass. Typically, the exam will last about 20-30 minutes and at least three questions will be asked about the program. The answer to each question will be assigned a score from 0-30 and the weighted average of the votes obtained in the single questions will represent the final score.
BIO/14 - PHARMACOLOGY - University credits: 10
Lessons: 80 hours
Professor:
Caffino Lucia
Shifts:
Turno
Professor:
Caffino LuciaSurname M-Z
Responsible
Lesson period
Second semester
Course syllabus
Pharmacovigilance and toxicology are two fundamental disciplines for the protection of public health that study the impact of drugs and chemical substances on the human body. Toxicology, defined as the study of the adverse effects of xenobiotics (e.g., drugs, pesticides, food additives, environmental pollutants, etc.), deals not only with the investigation of the harmful effects of exogenous agents on living organisms, but also with their mechanisms of action, safety evaluation, and risk assessment. Toxicology is a multidisciplinary science that draws upon the knowledge and methodologies of numerous fields, including biology, biochemistry, physiology, medicine, chemistry, mathematics, and physics. The aim of pharmacovigilance is to identify, assess, understand, and prevent adverse effects or any other problems related to the use of medicinal products after they have been placed on the market.
The aim of the course is to provide:
The fundamental principles required for the proper characterization of the adverse effects of xenobiotics, including the methods and approaches used in toxicological evaluation.
An understanding of the molecular mechanisms underlying adverse effects, with particular emphasis on pharmaceuticals.
Knowledge of organ-specific toxicity, focusing on the types of damage induced in individual organs and the substances responsible, particularly drugs.
An overview of the toxic effects associated with different classes of chemicals, including pesticides, metals, solvents, radiation, and natural toxins.
The course will specifically address the following topics:
Principles of general toxicology
Absorption, distribution, metabolism, and excretion (ADME)
Mechanisms of cellular injury and repair systems
Genotoxicity and chemical carcinogenesis
Immunotoxicology
Hematotoxicity
Developmental and reproductive toxicity
Hepatotoxicity
Nephrotoxicity
Neurotoxicity
Gastrointestinal toxicity
Cardiovascular toxicity
Pulmonary toxicity
Skin toxicity
Ocular toxicity
Drug-induced toxicity
Endocrine disruptors
Metal toxicity
Solvent toxicity
Pesticide toxicology
Food toxicology
Toxicology of biotechnological products
Natural toxins
Ionizing radiation
Fundamentals of occupational toxicology
Fundamentals of ecotoxicology and environmental fate
Risk assessment
European agencies involved in safety assessment
In vitro methods and New Approach Methodologies (NAMs)
Pharmacovigilance
Drug utilization studies and analysis of administrative healthcare databases
By the end of the course, students will have acquired the scientific knowledge necessary to understand the mechanisms of toxicity, evaluate toxicological data, and apply risk assessment principles in the fields of pharmaceuticals, chemicals, food safety, and public health.
The aim of the course is to provide:
The fundamental principles required for the proper characterization of the adverse effects of xenobiotics, including the methods and approaches used in toxicological evaluation.
An understanding of the molecular mechanisms underlying adverse effects, with particular emphasis on pharmaceuticals.
Knowledge of organ-specific toxicity, focusing on the types of damage induced in individual organs and the substances responsible, particularly drugs.
An overview of the toxic effects associated with different classes of chemicals, including pesticides, metals, solvents, radiation, and natural toxins.
The course will specifically address the following topics:
Principles of general toxicology
Absorption, distribution, metabolism, and excretion (ADME)
Mechanisms of cellular injury and repair systems
Genotoxicity and chemical carcinogenesis
Immunotoxicology
Hematotoxicity
Developmental and reproductive toxicity
Hepatotoxicity
Nephrotoxicity
Neurotoxicity
Gastrointestinal toxicity
Cardiovascular toxicity
Pulmonary toxicity
Skin toxicity
Ocular toxicity
Drug-induced toxicity
Endocrine disruptors
Metal toxicity
Solvent toxicity
Pesticide toxicology
Food toxicology
Toxicology of biotechnological products
Natural toxins
Ionizing radiation
Fundamentals of occupational toxicology
Fundamentals of ecotoxicology and environmental fate
Risk assessment
European agencies involved in safety assessment
In vitro methods and New Approach Methodologies (NAMs)
Pharmacovigilance
Drug utilization studies and analysis of administrative healthcare databases
By the end of the course, students will have acquired the scientific knowledge necessary to understand the mechanisms of toxicity, evaluate toxicological data, and apply risk assessment principles in the fields of pharmaceuticals, chemicals, food safety, and public health.
Prerequisites for admission
To successfully attend a Toxicology and Pharmacovigilance course, students should possess a solid background in the biological, chemical, and biomedical sciences. Essential knowledge includes cell and molecular biology, human physiology, biochemistry, and anatomy, which are necessary to understand the structure and function of organs and systems that may be affected by toxic substances.
Students should also have a sound understanding of general, organic, and pharmaceutical chemistry, including the main classes of chemical compounds, their physicochemical properties, and structure-activity relationships. Basic knowledge of pharmacology is highly recommended, as it provides the foundation for understanding the similarities and differences between therapeutic and toxic effects of drugs and other chemicals.
In addition, students should be able to interpret scientific data, read and understand scientific literature, and apply basic principles of the scientific method. These competencies will enable them to critically evaluate toxicological information and fully engage with the concepts presented throughout the course.
Students should also have a sound understanding of general, organic, and pharmaceutical chemistry, including the main classes of chemical compounds, their physicochemical properties, and structure-activity relationships. Basic knowledge of pharmacology is highly recommended, as it provides the foundation for understanding the similarities and differences between therapeutic and toxic effects of drugs and other chemicals.
In addition, students should be able to interpret scientific data, read and understand scientific literature, and apply basic principles of the scientific method. These competencies will enable them to critically evaluate toxicological information and fully engage with the concepts presented throughout the course.
Teaching methods
The course will be delivered primarily through face-to-face lectures supported by multimedia presentations and teaching materials made available to students. Learning activities will include case studies, critical discussion of practical examples related to drug (including pharmacovigilance) and chemical safety. Interactive sessions and classroom discussions will be encouraged to promote active student participation and the development of critical thinking skills.
Teaching Resources
The teaching materials used during the lectures will be made available to students. Recommended textbooks include:Casarett and Doull's Toxicology: The Basic Science of Poisons 9th Edition (Curtis D. Klaassen, Ed). Mc Graw Hill Education. 2018
Casarett & Doull. Elementi di tossicologia di John B. III Watkins, Curtis D. Klaassen. Ed. CEA
Galli, Corsini, Marinovich. Tossicologia, Ed. Piccin
Casarett & Doull. Elementi di tossicologia di John B. III Watkins, Curtis D. Klaassen. Ed. CEA
Galli, Corsini, Marinovich. Tossicologia, Ed. Piccin
Assessment methods and Criteria
Assessment of learning: oral exam, in which the learning of the topics covered, the ability of synthesis and connection will be evaluated. The student's ability to frame the problems of toxicological evaluation in the perspective of assessing human and environmental safety will be evaluated. The student will have to demonstrate that he/she has understood the key concepts and the main operational tools that characterize the safety assessment of xenobiotics and pharmacovigilance. Typically the exam will last about 30 minutes and at least five questions will be asked about the program. The answer to each question will be assigned a score from 0-30 and the weighted average of the scores obtained in the single questions will represent the final mark.
BIO/14 - PHARMACOLOGY - University credits: 10
Lessons: 80 hours
Professor:
Corsini Emanuela
Shifts:
Turno
Professor:
Corsini EmanuelaProfessor(s)
Reception:
9:00-18:00
Department of Pharmacological and Biomolecular Sciences, Via Balzaretti 9, Milano
Reception:
By telephone or e-mail appointment
Dip. di Scienze Farmacologiche e Biomolecolari 'Rodolfo Paoletti', Via Balzaretti 9, Milano