Ateneo - UPO

The basic principles of toxicokinetics and toxicodynamics that account for natural and synthetic xenobiotic toxic effects with special attention to drugs. Methodologies used to assess the risk of toxic substance exposure. Acquisition of the theoretical and methodological principles underlying pharmacovigilance. In addition, the course intends to provide the methodological tools required for analysis and processing of experimental data for quantitative determination of pharmacokinetic parameters.

- Cassarett and Doull: Elementi di tossicologia, Casa Editrice Ambrosiana. - Walter Balduini, Lucio Costa: Tossicologia generale e applicata ai farmaci, Edizioni EDRA. -Handouts of pharmacokinetics, provided in class.

The basic principles of toxicokinetics and toxicodynamics that account for natural and synthetic xenobiotic toxic effects with special attention to drugs. Methodologies used to assess the risk of toxic substance exposure. Acquisition of the theoretical and methodological principles underlying pharmacovigilance. In addition, the course intends to provide the methodological tools required for analysis and processing of experimental data for quantitative determination of pharmacokinetic parameters.

There are no preparatory requirements but optimal use of the course requires basic knowledge of anatomy, physiology, biochemistry, general pharmacology and pharmacognosy.

The course is structured in classroom lectures. In case of a new epidemiological emergency, all the lessons will be conducted remotely through audio/video lessons which will be uploaded to the Moodle platform (www.dir.uniupo.it). Practical exercises will be also planned to take place in the classroom. In case of a new epidemiologica emergency, practical exercises will be conducted remotely via Google Meet (https://meet.google.com)

Slides and all other materials will be available on the DIR platform (Didattica in Rete, www.dir.uniupo.it) Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The exam consists of a written test comprising 1 exercise of pharmacokinetics and 2 open questions on topics indicated in the course program and given during lectures. Each of them will be scored from 0 to 30. The written test is passed if the overall mean assessment will be equal or higher than 18 points out of 30 points. Incoming Erasmus students are given the option of taking the written exam in English

General principles of toxicology; mutagenesis and carcinogenesis; developmental toxicology; toxicology in drug development; classification of advers drug reactions; drug allergic reactions; pharmacogenetics; organ toxicology: hepatotoxicity, renal toxicity, respiratory system toxicity; cardiovascular toxicity; drugs of abuse toxicity; metals and pesticides toxicities; antidotes; toxicity of biotechnological drugs; drug interactions, pharmacoepidemiology; systematic reviews and meta-analyses; pharmacovigilance (active and passive), phytovigilance and cosmetics vigilance; ecopharmacovigilance. Principles of pharmacokinetics. Single intravenous or oral administration: determination of plasma half-life, plasma and renal clearance, and volume of distribution. Continuous infusion: calculation of plasma concentration at steady state. Repeated intravenous or oral administrations: determination of maximum and minimum plasma concentration at the steady state.

KNOWLEDGE AND UNDERSTANDING The students at the end of the teaching will know concepts relative to: - types of toxic effects and factors influencing xenobiotic toxicity; - general principles governing the estimation of the risk deriving from the exposure to chemical agents; - molecular and toxicokinetic mechanisms underlying the toxic effects induced by xenobiotics, with a particular focus on drugs. APPLYING KNOWLEDGE AND UNDERSTANDING The students will have the tools for evaluating the risk/benefit of drugs, and understanding the role of toxicology in the drug discovery and development process. The students will have the tools for solving pharmacokinetic and pharmacodynamic questions through experimental data processing. LIFELONG LEARNING SKILL, MAKING JUDGEMENTS, COMMUNICATION The students will be familiar with the key aspects of fundamental toxicology, and will have developed an insight in concepts and methods that will make the student able to critically assess new results in the field.