Pharmacy

Definition and areas of application of toxicology. Definition of toxicological risk. Purpose of toxicological studies. Risk assessment and management. Main regulatory references. Sources of toxicological data. The dose-response relationships for the identification of the correlation between exposure to toxicants and the appearance of toxic effects. Dose-Response curves. Safety margin and exposure. Characteristics of the toxic-target interaction. Individual variability in response to xenobiotics. The Application of Statistical Analysis in the Biomedical Sciences. Experimental toxicology. Descriptive, mechanistic, theoretical studies (structure-activity relationship). Descriptive toxicology studies on experimental animals: predictability and doses used; aims of the studies; factors influencing toxicity (species, strain, administration routes); controls. Studies of acute, subacute, subchronic, chronic toxicity. Duration of studies. Doses used; NOEL, NOAEL, LOEL, LOAEL. Animal testing: animal species used, outline of breeding techniques, housing conditions and rodent handling techniques. Alternative methods to animal experimentation. Legislative references (EU Directive 2010/63 and D. Lgs 26/14). The 3Rs principle. Extrapolation to humans of toxicological data. Toxicokinetic. Routes of exposure to xenobiotics. Absorption, distribution and excretion of xenobiotics. Interconnections between biokinetics and toxicity of chemicals. Main routes of toxicants exposure. The main anatomical barriers. Metabolism of xenobiotics. Detoxification and activation reactions; phase I and phase II reactions; first pass metabolism and pre-systemic elimination. Main factors responsible for the variability in the metabolism of xenobiotics (genetic variability, physiological and pathological states, diet, smoking, environmental factors). Mechanisms of toxicity. Formation, reactivity and target molecules of electrophiles, free radicals, nucleophiles. Detoxification systems; failure of detoxification. Characteristics of the target molecules. Toxic effects on the target molecules: dysfunction, destruction, formation of neoantigens. Cellular toxic effects: dysregulation of gene expression and 'activity in progress'. Toxic alteration of cellular homeostasis: alteration of energy metabolism; toxic effects of the increase of intracellular Ca ++; other mechanisms of cell toxicity. Mechanisms of molecular repair (proteins, lipids, DNA), cellular and tissue. Adverse drug reactions (ADR). Definitions of ADRs according to WHO (side effect, adverse event, adverse reaction, unexpected adverse reaction). Classification based on gravity, frequency, latency time. Rawlins & Thompson classification, DoTS classification. Overview of ADR management. Examples of adverse reactions for each category. Factors responsible for susceptibility to adverse reactions related to the patient and / or medication. Idiosyncratic reactions: definition and causes. Individual variability in response to xenobiotics. Genetic polymorphisms. Differences between idiosyncrasy and drug allergy. Examples of idiosyncratic reactions. Drug interactions. Mechanisms of interaction in the pharmaceutical phase (neutralization), pharmacokinetics (absorption / degradation during absorption, distribution, metabolism, excretion), pharmacodynamics (summation, synergism, addition, antagonism). Pharmacovigilance. Regional, national and international control board and legislation of Pharmacovigilance. Terminology, definitions and methods for monitoring adverse drug reactions. Reporting of adverse drug reactions. Role of the Pharmacist in the Pharmacovigilance system. Epidemiology: epidemiological studies for the characterization of toxicological risk in humans. Definition and purpose of causal, etiological or analytical epidemiology, clinical epidemiology, descriptive epidemiology, evaluative epidemiology. Epidemiological observational (descriptive and analytical) and experimental studies. Definition of risk and protection factor. Causality criteria, association measures and risk calculation. General scheme of an analytical study. Calculation and interpretation of relative risk and odds ratio. Developmental toxicology. Placental transfer of xenobiotics. Fetal distribution, metabolism and excretion of xenobiotics. Basic principles of teratogenesis. The teratogenesis in the period of pre-implantation, embryonic, fetal. Characteristics and mechanisms of toxicity of teratogens. Functional teratology. Examples of xenobiotics (drugs, environmental factors, maternal physio-pathological conditions, maternal habits) toxic for human embryos and fetus. Fetal alcohol syndrome and FASD (Fetal Alcohol Spectrum Disorder). Experimental methods for evaluating developmental toxicity. Chemical carcinogenesis: initiation, promotion and progression phases. Association between exposure to chemicals and the onset of cancer. Mechanism of action of chemical carcinogens. Genotoxic and non-genotoxic carcinogens. Experimental models for the evaluation of carcinogens. Genetic toxicology. Mechanisms of induction of genetic modifications and mechanisms of DNA repair. Experimental models in genetic toxicology. Organ toxicity: liver. Organ toxicity: kidney. Organ toxicity: toxic blood responses. Organ toxicity: toxic responses of the immune system. Organ toxicity: toxic responses of the reproductive system. Cardiovascular toxicity. Central nervous system toxicity. Endocrine system toxicity. Clinical toxicology. Principles of antidotism. Internal and external antidotes. Mechanisms of the main antidote phenomena (direct neutralization, by metabolic conversion, biotransformation block, antidotes that restore the normal functions). Food toxicology. Additives and food colors. Genetically modified organisms. Food security. Main regulatory references. Adverse reactions to foods or their ingredients. Chemical and microbial contamination of food. Food toxins. Environmental toxicology and ecotoxicology. Bioaccumulation and biomagnification. Bioindicators. Ecotoxicological tests / essays. Main regulatory references. Toxicology of substances of abuse. Physical and psychological drug addiction. Brain circuits and neurotransmitters involved in drug addiction. Classification by type of effect of the main classes of substances of abuse. Mechanisms of toxicity of some of the most common drugs of abuse (opium and derivatives, cannabis, ethanol, sedative-hypnotic drugs, gamma-hydroxybutyric acid-GHB and precursors, cocaine, ecstasy, anabolic steroids) and elements of treatment for cessation.

To understand the contents of the didactic activities foreseen by this course and to achieve the learning objectives, the student is recommended to possess at the beginning of the activities the basic knowledge of general pharmacology and pharmacotherapy, general physiology, biochemistry, human anatomy, and general pathology. These prerequisites are not a mandatory requirement, but they are strongly recommended for an optimal exam performance at the end of the course.

MANDATORY ATTENDANCE

The actual achievement of the expected learning outcomes by the student, in accordance with the aims of the course, is evaluated through an oral exams. Then following aspects will be evaluated and will contribute to the final score of the exam: the specific preparation of the student on the different course topics, the reasoning and judgment skills, and the ability to communicate with an appropriate technical language. The duration of the exam may vary depending on the student's skills. An average duration of about 25 minutes is conceivable. The exam will take place at the end of the course, according to pre-established dates that are published on the Infostud and e-learning platforms. To pass the exam a student must achieve a minimum score of 18/30, which corresponds to a sufficient preparation on the topics of the course (mainly on those presented during the lectures, and at least partly on those not presented in class), proving sufficient communication skills through the use of a technical language. To achieve a score of 30/30 cum laude, the student must demonstrate an excellent knowledge of all the topics of the course (including those not covered during the lectures), being able to link them in a logical and consistent way and showing excellent communication skills with technical terminology.

FRONTAL LESSONS

Definition and areas of application of toxicology. Definition of toxicological risk. Purpose of toxicological studies. Risk assessment and management. Main regulatory references. Sources of toxicological data. The dose-response relationships for the identification of the correlation between exposure to toxicants and the appearance of toxic effects. Dose-Response curves. Safety margin and exposure. Characteristics of the toxic-target interaction. Individual variability in response to xenobiotics. The Application of Statistical Analysis in the Biomedical Sciences. Experimental toxicology. Descriptive, mechanistic, theoretical studies (structure-activity relationship). Descriptive toxicology studies on experimental animals: predictability and doses used; aims of the studies; factors influencing toxicity (species, strain, administration routes); controls. Studies of acute, subacute, subchronic, chronic toxicity. Duration of studies. Doses used; NOEL, NOAEL, LOEL, LOAEL. Animal testing: animal species used, outline of breeding techniques, housing conditions and rodent handling techniques. Alternative methods to animal experimentation. Legislative references (EU Directive 2010/63 and D. Lgs 26/14). The 3Rs principle. Extrapolation to humans of toxicological data. Toxicokinetic. Routes of exposure to xenobiotics. Absorption, distribution and excretion of xenobiotics. Interconnections between biokinetics and toxicity of chemicals. Main routes of toxicants exposure. The main anatomical barriers. Metabolism of xenobiotics. Detoxification and activation reactions; phase I and phase II reactions; first pass metabolism and pre-systemic elimination. Main factors responsible for the variability in the metabolism of xenobiotics (genetic variability, physiological and pathological states, diet, smoking, environmental factors). Mechanisms of toxicity. Formation, reactivity and target molecules of electrophiles, free radicals, nucleophiles. Detoxification systems; failure of detoxification. Characteristics of the target molecules. Toxic effects on the target molecules: dysfunction, destruction, formation of neoantigens. Cellular toxic effects: dysregulation of gene expression and 'activity in progress'. Toxic alteration of cellular homeostasis: alteration of energy metabolism; toxic effects of the increase of intracellular Ca ++; other mechanisms of cell toxicity. Mechanisms of molecular repair (proteins, lipids, DNA), cellular and tissue. Adverse drug reactions (ADR). Definitions of ADRs according to WHO (side effect, adverse event, adverse reaction, unexpected adverse reaction). Classification based on gravity, frequency, latency time. Rawlins & Thompson classification, DoTS classification. Overview of ADR management. Examples of adverse reactions for each category. Factors responsible for susceptibility to adverse reactions related to the patient and / or medication. Idiosyncratic reactions: definition and causes. Individual variability in response to xenobiotics. Genetic polymorphisms. Differences between idiosyncrasy and drug allergy. Examples of idiosyncratic reactions. Drug interactions. Mechanisms of interaction in the pharmaceutical phase (neutralization), pharmacokinetics (absorption / degradation during absorption, distribution, metabolism, excretion), pharmacodynamics (summation, synergism, addition, antagonism). Pharmacovigilance. Regional, national and international control board and legislation of Pharmacovigilance. Terminology, definitions and methods for monitoring adverse drug reactions. Reporting of adverse drug reactions. Role of the Pharmacist in the Pharmacovigilance system. Epidemiology: epidemiological studies for the characterization of toxicological risk in humans. Definition and purpose of causal, etiological or analytical epidemiology, clinical epidemiology, descriptive epidemiology, evaluative epidemiology. Epidemiological observational (descriptive and analytical) and experimental studies. Definition of risk and protection factor. Causality criteria, association measures and risk calculation. General scheme of an analytical study. Calculation and interpretation of relative risk and odds ratio. Developmental toxicology. Placental transfer of xenobiotics. Fetal distribution, metabolism and excretion of xenobiotics. Basic principles of teratogenesis. The teratogenesis in the period of pre-implantation, embryonic, fetal. Characteristics and mechanisms of toxicity of teratogens. Functional teratology. Examples of xenobiotics (drugs, environmental factors, maternal physio-pathological conditions, maternal habits) toxic for human embryos and fetus. Fetal alcohol syndrome and FASD (Fetal Alcohol Spectrum Disorder). Experimental methods for evaluating developmental toxicity. Chemical carcinogenesis: initiation, promotion and progression phases. Association between exposure to chemicals and the onset of cancer. Mechanism of action of chemical carcinogens. Genotoxic and non-genotoxic carcinogens. Experimental models for the evaluation of carcinogens. Genetic toxicology. Mechanisms of induction of genetic modifications and mechanisms of DNA repair. Experimental models in genetic toxicology. Organ toxicity: liver. Organ toxicity: kidney. Organ toxicity: toxic blood responses. Organ toxicity: toxic responses of the immune system. Organ toxicity: toxic responses of the reproductive system. Cardiovascular toxicity. Central nervous system toxicity. Endocrine system toxicity. Clinical toxicology. Principles of antidotism. Internal and external antidotes. Mechanisms of the main antidote phenomena (direct neutralization, by metabolic conversion, biotransformation block, antidotes that restore the normal functions). Food toxicology. Additives and food colors. Genetically modified organisms. Food security. Main regulatory references. Adverse reactions to foods or their ingredients. Chemical and microbial contamination of food. Food toxins. Environmental toxicology and ecotoxicology. Bioaccumulation and biomagnification. Bioindicators. Ecotoxicological tests / essays. Main regulatory references. Toxicology of substances of abuse. Physical and psychological drug addiction. Brain circuits and neurotransmitters involved in drug addiction. Classification by type of effect of the main classes of substances of abuse. Mechanisms of toxicity of some of the most common drugs of abuse (opium and derivatives, cannabis, ethanol, sedative-hypnotic drugs, gamma-hydroxybutyric acid-GHB and precursors, cocaine, ecstasy, anabolic steroids) and elements of treatment for cessation.

To understand the contents of the didactic activities foreseen by this course and to achieve the learning objectives, the student is recommended to possess at the beginning of the activities the basic knowledge of general pharmacology and pharmacotherapy, general physiology, biochemistry, human anatomy, and general pathology. These prerequisites are not a mandatory requirement, but they are strongly recommended for an optimal exam performance at the end of the course.

MANDATORY ATTENDANCE

The actual achievement of the expected learning outcomes by the student, in accordance with the aims of the course, is evaluated through an oral exams. Then following aspects will be evaluated and will contribute to the final score of the exam: the specific preparation of the student on the different course topics, the reasoning and judgment skills, and the ability to communicate with an appropriate technical language. The duration of the exam may vary depending on the student's skills. An average duration of about 25 minutes is conceivable. The exam will take place at the end of the course, according to pre-established dates that are published on the Infostud and e-learning platforms. To pass the exam a student must achieve a minimum score of 18/30, which corresponds to a sufficient preparation on the topics of the course (mainly on those presented during the lectures, and at least partly on those not presented in class), proving sufficient communication skills through the use of a technical language. To achieve a score of 30/30 cum laude, the student must demonstrate an excellent knowledge of all the topics of the course (including those not covered during the lectures), being able to link them in a logical and consistent way and showing excellent communication skills with technical terminology.

FRONTAL LESSONS

Definition and areas of application of toxicology. Definition of toxicological risk. Purpose of toxicological studies. Risk assessment and management. Main regulatory references. Sources of toxicological data. The dose-response relationships for the identification of the correlation between exposure to toxicants and the appearance of toxic effects. Dose-Response curves. Safety margin and exposure. Characteristics of the toxic-target interaction. Individual variability in response to xenobiotics. The Application of Statistical Analysis in the Biomedical Sciences. Experimental toxicology. Descriptive, mechanistic, theoretical studies (structure-activity relationship). Descriptive toxicology studies on experimental animals: predictability and doses used; aims of the studies; factors influencing toxicity (species, strain, administration routes); controls. Studies of acute, subacute, subchronic, chronic toxicity. Duration of studies. Doses used; NOEL, NOAEL, LOEL, LOAEL. Animal testing: animal species used, outline of breeding techniques, housing conditions and rodent handling techniques. Alternative methods to animal experimentation. Legislative references (EU Directive 2010/63 and D. Lgs 26/14). The 3Rs principle. Extrapolation to humans of toxicological data. Toxicokinetic. Routes of exposure to xenobiotics. Absorption, distribution and excretion of xenobiotics. Interconnections between biokinetics and toxicity of chemicals. Main routes of toxicants exposure. The main anatomical barriers. Metabolism of xenobiotics. Detoxification and activation reactions; phase I and phase II reactions; first pass metabolism and pre-systemic elimination. Main factors responsible for the variability in the metabolism of xenobiotics (genetic variability, physiological and pathological states, diet, smoking, environmental factors). Mechanisms of toxicity. Formation, reactivity and target molecules of electrophiles, free radicals, nucleophiles. Detoxification systems; failure of detoxification. Characteristics of the target molecules. Toxic effects on the target molecules: dysfunction, destruction, formation of neoantigens. Cellular toxic effects: dysregulation of gene expression and 'activity in progress'. Toxic alteration of cellular homeostasis: alteration of energy metabolism; toxic effects of the increase of intracellular Ca ++; other mechanisms of cell toxicity. Mechanisms of molecular repair (proteins, lipids, DNA), cellular and tissue. Adverse drug reactions (ADR). Definitions of ADRs according to WHO (side effect, adverse event, adverse reaction, unexpected adverse reaction). Classification based on gravity, frequency, latency time. Rawlins & Thompson classification, DoTS classification. Overview of ADR management. Examples of adverse reactions for each category. Factors responsible for susceptibility to adverse reactions related to the patient and / or medication. Idiosyncratic reactions: definition and causes. Individual variability in response to xenobiotics. Genetic polymorphisms. Differences between idiosyncrasy and drug allergy. Examples of idiosyncratic reactions. Drug interactions. Mechanisms of interaction in the pharmaceutical phase (neutralization), pharmacokinetics (absorption / degradation during absorption, distribution, metabolism, excretion), pharmacodynamics (summation, synergism, addition, antagonism). Pharmacovigilance. Regional, national and international control board and legislation of Pharmacovigilance. Terminology, definitions and methods for monitoring adverse drug reactions. Reporting of adverse drug reactions. Role of the Pharmacist in the Pharmacovigilance system. Epidemiology: epidemiological studies for the characterization of toxicological risk in humans. Definition and purpose of causal, etiological or analytical epidemiology, clinical epidemiology, descriptive epidemiology, evaluative epidemiology. Epidemiological observational (descriptive and analytical) and experimental studies. Definition of risk and protection factor. Causality criteria, association measures and risk calculation. General scheme of an analytical study. Calculation and interpretation of relative risk and odds ratio. Developmental toxicology. Placental transfer of xenobiotics. Fetal distribution, metabolism and excretion of xenobiotics. Basic principles of teratogenesis. The teratogenesis in the period of pre-implantation, embryonic, fetal. Characteristics and mechanisms of toxicity of teratogens. Functional teratology. Examples of xenobiotics (drugs, environmental factors, maternal physio-pathological conditions, maternal habits) toxic for human embryos and fetus. Fetal alcohol syndrome and FASD (Fetal Alcohol Spectrum Disorder). Experimental methods for evaluating developmental toxicity. Chemical carcinogenesis: initiation, promotion and progression phases. Association between exposure to chemicals and the onset of cancer. Mechanism of action of chemical carcinogens. Genotoxic and non-genotoxic carcinogens. Experimental models for the evaluation of carcinogens. Genetic toxicology. Mechanisms of induction of genetic modifications and mechanisms of DNA repair. Experimental models in genetic toxicology. Organ toxicity: liver. Organ toxicity: kidney. Organ toxicity: toxic blood responses. Organ toxicity: toxic responses of the immune system. Organ toxicity: toxic responses of the reproductive system. Cardiovascular toxicity. Central nervous system toxicity. Endocrine system toxicity. Clinical toxicology. Principles of antidotism. Internal and external antidotes. Mechanisms of the main antidote phenomena (direct neutralization, by metabolic conversion, biotransformation block, antidotes that restore the normal functions). Food toxicology. Additives and food colors. Genetically modified organisms. Food security. Main regulatory references. Adverse reactions to foods or their ingredients. Chemical and microbial contamination of food. Food toxins. Environmental toxicology and ecotoxicology. Bioaccumulation and biomagnification. Bioindicators. Ecotoxicological tests / essays. Main regulatory references. Toxicology of substances of abuse. Physical and psychological drug addiction. Brain circuits and neurotransmitters involved in drug addiction. Classification by type of effect of the main classes of substances of abuse. Mechanisms of toxicity of some of the most common drugs of abuse (opium and derivatives, cannabis, ethanol, sedative-hypnotic drugs, gamma-hydroxybutyric acid-GHB and precursors, cocaine, ecstasy, anabolic steroids) and elements of treatment for cessation.

To understand the contents of the didactic activities foreseen by this course and to achieve the learning objectives, the student is recommended to possess at the beginning of the activities the basic knowledge of general pharmacology and pharmacotherapy, general physiology, biochemistry, human anatomy, and general pathology. These prerequisites are not a mandatory requirement, but they are strongly recommended for an optimal exam performance at the end of the course.

MANDATORY ATTENDANCE

The actual achievement of the expected learning outcomes by the student, in accordance with the aims of the course, is evaluated through an oral exams. Then following aspects will be evaluated and will contribute to the final score of the exam: the specific preparation of the student on the different course topics, the reasoning and judgment skills, and the ability to communicate with an appropriate technical language. The duration of the exam may vary depending on the student's skills. An average duration of about 25 minutes is conceivable. The exam will take place at the end of the course, according to pre-established dates that are published on the Infostud and e-learning platforms. To pass the exam a student must achieve a minimum score of 18/30, which corresponds to a sufficient preparation on the topics of the course (mainly on those presented during the lectures, and at least partly on those not presented in class), proving sufficient communication skills through the use of a technical language. To achieve a score of 30/30 cum laude, the student must demonstrate an excellent knowledge of all the topics of the course (including those not covered during the lectures), being able to link them in a logical and consistent way and showing excellent communication skills with technical terminology.

FRONTAL LESSONS

Definition and areas of application of toxicology. Definition of toxicological risk. Purpose of toxicological studies. Risk assessment and management. Main regulatory references. Sources of toxicological data. The dose-response relationships for the identification of the correlation between exposure to toxicants and the appearance of toxic effects. Dose-Response curves. Safety margin and exposure. Characteristics of the toxic-target interaction. Individual variability in response to xenobiotics. The Application of Statistical Analysis in the Biomedical Sciences. Experimental toxicology. Descriptive, mechanistic, theoretical studies (structure-activity relationship). Descriptive toxicology studies on experimental animals: predictability and doses used; aims of the studies; factors influencing toxicity (species, strain, administration routes); controls. Studies of acute, subacute, subchronic, chronic toxicity. Duration of studies. Doses used; NOEL, NOAEL, LOEL, LOAEL. Animal testing: animal species used, outline of breeding techniques, housing conditions and rodent handling techniques. Alternative methods to animal experimentation. Legislative references (EU Directive 2010/63 and D. Lgs 26/14). The 3Rs principle. Extrapolation to humans of toxicological data. Toxicokinetic. Routes of exposure to xenobiotics. Absorption, distribution and excretion of xenobiotics. Interconnections between biokinetics and toxicity of chemicals. Main routes of toxicants exposure. The main anatomical barriers. Metabolism of xenobiotics. Detoxification and activation reactions; phase I and phase II reactions; first-pass metabolism and pre-systemic elimination. Main factors responsible for the variability in the metabolism of xenobiotics (genetic variability, physiological and pathological states, diet, smoking, environmental factors). Mechanisms of toxicity. Formation, reactivity and target molecules of electrophiles, free radicals, nucleophiles. Detoxification systems; failure of detoxification. Characteristics of the target molecules. Toxic effects on the target molecules: dysfunction, destruction, formation of neoantigens. Cellular toxic effects: dysregulation of gene expression and 'activity in progress'. Toxic alteration of cellular homeostasis: alteration of energy metabolism; toxic effects of the increase of intracellular Ca ++; other mechanisms of cell toxicity. Mechanisms of molecular repair (proteins, lipids, DNA), cellular and tissue. Adverse drug reactions (ADR). Definitions of ADRs according to WHO (side effect, adverse event, adverse reaction, unexpected adverse reaction). Classification based on gravity, frequency, latency time. Rawlins & Thompson classification, DoTS classification. Overview of ADR management. Examples of adverse reactions for each category. Factors responsible for susceptibility to adverse reactions related to the patient and/or medication. Idiosyncratic reactions: definition and causes. Individual variability in response to xenobiotics. Genetic polymorphisms. Differences between idiosyncrasy and drug allergy. Examples of idiosyncratic reactions. Drug interactions. Mechanisms of interaction in the pharmaceutical phase (neutralization), pharmacokinetics (absorption/degradation during absorption, distribution, metabolism, excretion), pharmacodynamics (summation, synergism, addition, antagonism). Pharmacovigilance. Regional, national and international control board and legislation of Pharmacovigilance. Terminology, definitions and methods for monitoring adverse drug reactions. Reporting of adverse drug reactions. Role of the Pharmacist in the Pharmacovigilance system. Epidemiology: epidemiological studies for the characterization of toxicological risk in humans. Definition and purpose of causal, etiological or analytical epidemiology, clinical epidemiology, descriptive epidemiology, evaluative epidemiology. Epidemiological observational (descriptive and analytical) and experimental studies. Definition of risk and protection factor. Causality criteria, association measures and risk calculation. General scheme of an analytical study. Calculation and interpretation of relative risk and odds ratio. Developmental toxicology. Placental transfer of xenobiotics. Fetal distribution, metabolism and excretion of xenobiotics. Basic principles of teratogenesis. The teratogenesis in the period of pre-implantation, embryonic, fetal. Characteristics and mechanisms of toxicity of teratogens. Functional teratology. Examples of xenobiotics (drugs, environmental factors, maternal physio-pathological conditions, maternal habits) toxic for human embryos and fetus. Fetal alcohol syndrome and FASD (Fetal Alcohol Spectrum Disorder). Experimental methods for evaluating developmental toxicity. Chemical carcinogenesis: initiation, promotion and progression phases. Association between exposure to chemicals and the onset of cancer. Mechanism of action of chemical carcinogens. Genotoxic and non-genotoxic carcinogens. Experimental models for the evaluation of carcinogens. Genetic toxicology. Mechanisms of induction of genetic modifications and mechanisms of DNA repair. Experimental models in genetic toxicology. Organ toxicity: liver. Organ toxicity: kidney. Organ toxicity: toxic blood responses. Organ toxicity: toxic responses of the immune system. Organ toxicity: toxic responses of the reproductive system. Cardiovascular toxicity. Central nervous system toxicity. Endocrine system toxicity. Clinical toxicology. Principles of antidotism. Internal and external antidotes. Mechanisms of the main antidote phenomena (direct neutralization, by metabolic conversion, biotransformation block, antidotes that restore the normal functions). Food toxicology. Additives and food colors. Genetically modified organisms. Food security. Main regulatory references. Adverse reactions to foods or their ingredients. Chemical and microbial contamination of food. Food toxins. Environmental toxicology and ecotoxicology. Bioaccumulation and biomagnification. Bioindicators. Ecotoxicological tests/essays. Main regulatory references. Toxicology of substances of abuse. Physical and psychological drug addiction. Brain circuits and neurotransmitters involved in drug addiction. Classification by type of effect of the main classes of substances of abuse. Mechanisms of toxicity of some of the most common drugs of abuse (opium and derivatives, cannabis, ethanol, sedative-hypnotic drugs, gamma-hydroxybutyric acid-GHB and precursors, cocaine, ecstasy, anabolic steroids) and elements of treatment for cessation.

To understand the contents of the didactic activities foreseen by this course and to achieve the learning objectives, the student is recommended to possess at the beginning of the activities the basic knowledge of general pharmacology and pharmacotherapy, general physiology, biochemistry, human anatomy, and general pathology. These prerequisites are not a mandatory requirement, but they are strongly recommended for an optimal exam performance at the end of the course.

Casarett & Doull' s "Tossicologia - I fondamenti dell'azione delle sostanze tossiche", settima edizione 2010, Editore EMSI Casarett & Doull "Elementi di Tossicologia", 2013 casa editrice Ambrosiana Corrado L. Galli, Emanuela Corsini, Marina Marinovich "Tossicologia", terza edizione 2016, Piccin Editore Casarett & Doull's Toxicology: The Basic Science of Poisons 8th edition 2013 McGraw-Hill Medical

The teaching method mainly includes lectures, during which there will be continuous references to the recommended textbooks and to the didactic material provided by the professor, in order to guide the student in the approach to the textbook or to bibliographic sources in general. The lectures will address a large part of the topics included in the program, focusing in particular on topics more difficult for the student to understand and suggesting links between the various topics of the program that can help the student to deal with the study even independently. During the lessons, the student will be invited to answer simple questions that recall or link to topics already dealt with, in this course or in the other courses of the teaching cycle, in order to stimulate him/her to develop judgment and communication skills. Furthermore, simulations of bibliographic research are also foreseen through the use of scientific databases (e.g., Pubmed) or websites of public or private organizations in the area of Pharmacology (e.g., AIFA, ISS, Sitox), in order to provide the student indications on the use of such sources to develop learning skills necessary for his/her autonomous continuous education in this field.

Course attendance is mandatory and will be monitored. Attendance is necessary as it allows to obtain updated information, not necessarily reported in the textbooks, and helps to achieve a valid method of approach to the study of the various topics.

The actual achievement of the expected learning outcomes by the student, in accordance with the aims of the course, is evaluated through a combination of written and oral exams. The following aspects will be evaluated and will contribute to the final score of the exam: the specific preparation of the student on the different course topics, the reasoning and judgment skills, and the ability to communicate with an appropriate technical language. The duration of the written exam will last approximately 30 minutes up to 2 hours (depending on the type of exam) whereas the duration of the oral exam may vary depending on the student's skills. The average duration of about 20 minutes is conceivable. The exam will take place at the end of the course, almost monthly (except for the month of August), according to pre-established dates that are published on the Infostud and e-learning platforms. To pass the exam a student must achieve a minimum score of 18/30, which corresponds to sufficient preparation on the topics of the course (mainly on those presented during the lectures, and at least partly on those not presented in class), proving sufficient communication skills through the use of a technical language. To achieve a score of 30/30 cum laude, the student must demonstrate an excellent knowledge of all the topics of the course (including those not covered during the lectures), being able to link them in a logical and consistent way, and showing excellent communication skills with technical terminology.

The teaching method mainly includes lectures, during which there will be continuous references to the recommended textbooks and to the didactic material provided by the professor, in order to guide the student in the approach to the textbook or to bibliographic sources in general. The lectures will address a large part of the topics included in the program, focusing in particular on topics more difficult for the student to understand and suggesting links between the various topics of the program that can help the student to deal with the study even independently. During the lessons, the student will be invited to answer simple questions that recall or link to topics already dealt with, in this course or in the other courses of the teaching cycle, in order to stimulate him/her to develop judgment and communication skills. Furthermore, simulations of bibliographic research are also foreseen through the use of scientific databases (e.g., Pubmed) or websites of public or private organizations in the area of Pharmacology (e.g., AIFA, ISS, Sitox), in order to provide the student indications on the use of such sources to develop learning skills necessary for his/her autonomous continuous education in this field.