E3260 Applied toxicology and pharmacology

Faculty of Science
Autumn 2025
Extent and Intensity
2/1/0. 3 credit(s) (fasci plus compl plus > 4). Type of Completion: zk (examination).
In-person direct teaching
Teacher(s)
doc. RNDr. Pavel Babica, Ph.D. (lecturer)
RNDr. Iva Sovadinová, Ph.D. (lecturer)
doc. PharmDr. Ondřej Zendulka, Ph.D. (lecturer)
doc. Mgr. Klára Hilscherová, Ph.D. (lecturer)
prof. RNDr. Luděk Bláha, Ph.D. (lecturer)
Guaranteed by
doc. RNDr. Pavel Babica, Ph.D.
RECETOX – Faculty of Science
Contact Person: doc. RNDr. Pavel Babica, Ph.D.
Supplier department: RECETOX – Faculty of Science
Prerequisites
The course does not have any specific pre-requisites. Basic knowledge in (molecular and cell) biology and (bio) chemistry is advantagoues.
Course Enrolment Limitations
The course is also offered to the students of the fields other than those the course is directly associated with.
fields of study / plans the course is directly associated with
Course objectives
The aim of the course is to introduce students to the basic principles and methods used in toxicology and pharmacology, with an emphasis on contemporary approaches that leverage mechanistic knowledge to understand therapeutic or adverse effects at both individual and population levels. Students will learn current concepts in the assessment of toxicokinetics and pharmacokinetics of various chemicals, including environmental toxicants and drug candidates. The course will also address toxicodynamics and pharmacodynamics, focusing on the key mechanisms underlying toxicological and pharmacological activities and on methods for their evaluation using various computational and experimental models and assays. Students will be introduced to tools for interpreting mechanistic knowledge in toxicological and pharmacological contexts, for extrapolating it to higher levels of biological organization, and for in vitro–in vivo extrapolation. Applications of these tools and approaches in preclinical research, hazard identification, and chemical risk assessment will be presented. Students will also gain an understanding of the current legislative framework for the use of advanced, animal-free testing methods in toxicity assessment, as well as emerging trends and concepts in predictive toxicology and preclinical research.
Learning outcomes
A student who successfully completes the course will be able to:

-Describe how various substances affect biological systems at all levels of biological organization, explain their mechanisms of action, and understand how these substances are metabolized and excreted from the body.

-Apply theoretical knowledge in practical situations, such as in the development of new drugs, chemical safety assessment, or the management of poisoning cases. Explain the main computational and experimental methods, models, and procedures used to evaluate pharmacological activity or to identify disruptions in key toxicity mechanisms leading to therapeutic or adverse effects.

Understand the principles, applications, and current validation status of in vitro tests used to assess specific adverse effects and therapeutic outcomes, and how these tests can be extrapolated from in vitro to in vivo contexts.

Recognize regulations and guidelines for chemical assessment, including the use of advanced, animal-free tests and models in toxicological and pharmacological evaluations.

Understand the applicability domains of alternative (in vitro) versus standard (in vivo) methods for toxicity and pharmacology testing, including their strengths, limitations, and potential for routine use.

Navigate contemporary concepts and approaches in toxicology and pharmacology that enhance the reliability and predictive power of chemical effect assessments.

Students will acquire competencies in assessing the impact of chemical substances on the environment and human health, applying innovative and ethical toxicity testing methods in accordance with the 3R principles, and analyzing environmental data and impacts, including aspects of health, safety, and sustainability. They will gain an understanding of European strategies such as the Zero Pollution Ambition, the Chemicals Strategy for Sustainability, and the Pharmaceutical Strategy for Europe. These skills will enable them to identify and evaluate risks associated with chemical exposure, apply modern approaches (in vitro, in silico, in chemico), and translate assessment results into professional practice and regulatory decision-making.
Syllabus
  • 1) Introduction to Toxicology and Classification of Hazardous Chemicals
  • Hazard and risk, points of departure.
  • Classification of hazardous chemicals and health hazard categories.
  • Classification of chemicals and mixtures varies depending on their use and potential risks.
  • 2) Introduction to Pharmacology and Drug Classification
  • Safety and efficacy, therapeutic index, proof of mechanism, proof of concept.
  • Drug nomenclature (chemical name, generic name, INN, brand name)
  • Drug classification (by chemical structure, component characteristics, ATC group)
  • Assignment of individual tasks (I. scientific report, II. presentation for interactive seminar)
  • 3) Toxicokinetics and Pharmacokinetics (ADME)
  • Concepts of toxicokinetics/pharmacokinetics (ADME): assessment of absorption, distribution, metabolism, and excretion.
  • Methods for studying ADME: in vitro and in vivo approaches, including experimental techniques and model systems.
  • Physiologically Based Pharmacokinetic (PBPK) and Toxicokinetic (PBTK) modeling.
  • 4–5) Toxicodynamics and Pharmacodynamics, Basic Mechanisms of Toxicity and Effects
  • Concept of Adverse Outcome Pathways (AOPs).
  • Interactions of chemicals with biomacromolecules: mechanisms of chemical interactions with proteins (receptors, enzymes, ion channels, transport proteins), nucleic acids, and (phospho)lipids.
  • Cellular level: cell viability and metabolic activity, redox balance, regulation of the cell cycle and cell death.
  • Tissue level: regulation of intercellular communication and tissue homeostasis, inflammation.
  • Organ level: specific organ responses (e.g., nervous system, endocrine system, liver).
  • Organism level: apical and systemic responses.
  • 6) Work on individual assignment (report preparation and submission & peer review)
  • 7–8) Chemical Safety and Pharmaceutical Assessment
  • Overview of the regulatory landscape for chemical safety and pharmaceutical evaluation.
  • Integration of New Approach Methodologies (NAMs) into regulatory frameworks.
  • Next-Generation Risk Assessment (NGRA)
  • 8) Guest lecture by expert from practice (e.g., Dr. Kubincová, VÚOS Toxicology Centre, OECD National Coordinator of the Test Guidelines Programme)
  • 9–10) New Approach Methodologies (NAMs) and In Vitro–In Vivo Extrapolation
  • Introduction to NAMs for toxicity testing and risk assessment.
  • Techniques for extrapolating in vitro data to in vivo contexts, including Quantitative In Vitro–In Vivo Extrapolation (QIVIVE).
  • Pre-validation and validation of testing methods.
  • Applications and limitations of these models in toxicity and therapeutic effect assessment.
  • 11) Work on individual assignment (preparation of presentation for interactive seminar)
  • 12–13) Interactive Seminar
  • Student presentations / “flipped classroom”
Literature
  • Translational medicine : molecular pharmacology and drug discovery. Edited by Robert A. Meyers. Weinheim: Wiley-VCH, 2018, 1064 stran. ISBN 9783527336593. info
  • KUBINCOVÁ, Petra; Jiří NOVÁK and Iva SOVADINOVÁ. Acute Systemic Toxicity: Alternative in Vivo and in Vitro Methods. CHEMICKÉ LISTY. Praha: Česká společnost chemická, 2016, vol. 110, No 2, p. 118-125. ISSN 0009-2770. info
  • FOWLER, Bruce A. Molecular biological markers for toxicology and risk assessment. Amsterdam: Elsevier, 2016, ix, 153. ISBN 9780128095898. info
  • Predictive toxicology : from vision to reality. Edited by Friedlieb Pfannkuch - Laura Suter-Dick. Weinheim: Wiley-VCH, 2015, xxv, 404. ISBN 9783527336081. info
Teaching methods
The course combines
(i) lectures, i.e. presentations and face-to-face interactions (12 x 2 hours per week, attendance non obligatory), (ii) homework - a written report and evaluation of a written report form colleague (4 h), preparation for interactive seminar (6 h), (iii) 2 x interactive 2 h seminars, with each student presenting on a topic selected in the start of the course.
(i) Lectures – presentations and in-person interaction (12 × 2 hours per week; attendance is not mandatory)
(ii) Homework – a written report and peer review of a colleague’s report (4 hours), preparation for the interactive seminar (6 hours)
(iii) Two interactive seminars, each lasting 2 hours, during which each student (or group of students) presents on a topic selected at the beginning of the course.
Assessment methods
Completion of the course and final assessment consists of the following components:

1) Preparation of a scientific report:
Preparation of a scientific report on a selected chemical substance according to the provided template (submitted mid-semester). [Assessment: Completed/Not completed]

2) Peer review and feedback:
Evaluation and feedback on a scientific report prepared by another student (mid-semester). [Assessment: Completed/Not completed]

3) Presentation preparation:
Preparation of a presentation (approximately 10 minutes + 10 minutes discussion) on current approaches to evaluating a selected type of toxicity/adverse outcome (held at the end of the semester – week 12 or 13). [Assessment: Completed/Not completed]

4) Final exam:
Final written test with the possibility of a follow-up oral examination (during the examination period). The test consists of 24 closed-ended and 2 open-ended questions. Graded on an A–F scale. A minimum score of 60% is required to pass. An oral examination may follow the written test.

Note: Without completing assignments 1–3 during the semester (assessed as Completed/Not completed), it is not possible to take the final exam. The final grade is based solely on the result of the final exam (item 4).
Náhradní absolvování
For the theoretical parts, students can be provided with study materials (slides, texts, videorecordings of the lectures). Practical / seminar case studies can be agreed on individual basis.
Language of instruction
Czech
Further Comments
The course is taught annually.
The course is taught every week.
  • Enrolment Statistics (recent)
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