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Research Methods in Pre-clinical Pharmacology

Code: 42361
Credits: 9
2026/2027
Degree programme Type Course
Pharmacology OP 0

Contact lecturer

Name :
Francesc Jimenez Altayo
Email :
francesc.jimenez@uab.cat

Teaching staff

Carles Cristòfol Adell
Sara Bertobillo Cunill
Vicente Martinez Perea
Angel Gonzalez Wong
Joaquim Hernández Martín
Lydia Gimenez Llort
Anna Maria Pujol Altarriba
Alheli Rodriguez Cortes

Teaching staff (external to UAB)

D. López
A. Guzmán
G. Encina
L. Canut
M. Aulí
J. L. Montero
N. Prats
L. Navarro
A. Norniella
R. Mollà
J.M. Cendros

Group languages

You can consult this information at the end of the document.

Prerequisites

There are no special prerequisites.

Objectives

To apply basic pharmacological and methodological knowledge to develop preclinical drug research and interpret the results.

Learning outcomes

  1. Generate innovative ideas.
  2. Plan, design, use and interpret studies (not on humans) with the aim of evaluating the effects of drugs and their mechanism of action.
  3. Plan, design, use and interpret studies (not on humans) with the aim of evaluating the time course of drug concentration in biological tissues and its relation to the effects observed.
  4. Plan, design, use and interpret studies (not on humans) with the aim of evaluating toxicity and possible adverse reactions.
  5. Recognise and apply the ethical and quality requirements for conducting non-clinical research with drugs.
  6. Apply models to describe and predict the time course of drug concentrations and their pharmacological response.
  7. Interpret models to describe and predict the time course of drug concentrations and their pharmacological response

Contents

a) Evaluation and validation of a pharmacological target. Molecular screening: automation and high performance. Levels of pharmacological research: computer (in silica), cells, organs, animals, humans. In vitro studies: molecular for the evaluation of targets, cell cultures (biochemical and molecular), isolated organs (physiological, biochemical and molecular). Ex vivo studies. Methodologies used in in vivo studies: conscious animal and anesthetized animal (measurement of blood pressure). Animal models of diseases induced by administration of compounds, by surgical intervention or by genetic manipulation. Methodologies for studies of psychotropic drugs.


b) In silico studies. In vitro studies: physical-chemical characterization (release, dissolution). In vitro studies: metabolism. In vivo studies: handling of animals, choice of species. In vivo studies: design. Microdialysis techniques. Plasma protein binding. Animal / human extrapolation (allometry): data analysis. Toxicokinetics and special pharmacokinetics.


c) Mechanisms of toxicity. In vitro toxicity studies. In vivo toxicity studies: single administration. In vivo toxicity studies: repeated administration. Toxic-anatomopathology. Reproductive toxicology: infertility, teratogenicity (embryotoxicity). Genotoxicity Carcinogenesis Phototoxicity Immunotoxicity Local tolerability Behavior tests


d) Ethics of animal research. Ethical committees BPLs: Good Laboratory Practices. Guidelines for pre-clinical research of Regulatory Agencies. Legislation. Preclinical information for registration. Study of patent situation.


e) Models, development strategies / techniques: empirical, mechanistic. Theory of statistical moments. Convolution / deconvolution: theory and applications. Non-linear adjustment. Population approximation. Sensitivity analysis and biases: strategies and applications.

Learning activities and methodology

Title Hours ECTS Learning outcomes
Study, written works ... 127 5.08 1, 2, 3, 4, 5, 6, 7
Classroom practices (PAUL) 11 0.44 1, 2, 3, 4, 5, 6, 7
Practical Experimental Laboratory (PLAB) 7 0.28 1, 2, 3, 4, 5, 6, 7
Review of papers 24 0.96 1, 2, 3, 4, 5, 6, 7
Master Class (TE) 50 2 1, 2, 3, 4, 5, 6, 7
Unscheduled tutorials 3 0.12 1, 2, 3, 4, 5, 6, 7

The final grade is the arithmetic mean of the grades obtained in the subjects that compose it.


Use of Artificial Intelligence (AI): The use of AI technologies is permitted only for support tasks (such as information search, text correction, or translations) and in specific activities as indicated. Students must clearly identify the parts generated with AI, specify the tools used, and include a critical reflection on how these influenced the process and final outcome. Non-transparent use of AI will be considered a breach of academic integrity and may result in penalties.

Annotation: within the schedule set by the centre or degree programme, 15 minutes of one class will be reserved for students to evaluate their lecturers and their courses or modules through questionnaires.

Assessment

Continuous assessment activities

Title Weight Hours ECTS Learning outcomes
Attendance and participation 10 % 0 0 1, 2, 3, 4, 5, 6, 7
Oral presentations 42,5 % 2 0.08 1, 2, 3, 4, 5, 6, 7
Short questions exam 47,5 % 1 0.04 1, 2, 3, 4, 5, 6, 7

The final grade is the arithmetic mean of the grades obtained in the subjects that compose it.


Students who do not take both the theoretical and practical assessment tests will be considered \"Not Evaluable\", exhausting their rights to enroll in the subject.

This subject/module does not provide for the single assessment system.


Any irregularity in an assessment activity —academic misconduct, plagiarism, or improper use of AI, unless such use is expressly authorised in the course guide— that may lead to a significant change in the mark shall result in that assessment activity being awarded a mark of 0. If the course guide establishes that obtaining a minimum mark in that assessment activity is an essential requirement for passing the course, or if several irregularities occur in the assessment activities of the same course, the final mark for that course shall be 0. In addition, disciplinary proceedings may be initiated against any student who commits any of these irregularities.

Bibliography

1. Textbooks and conceptual foundations

  1. Brunton LL, Knollmann BC, editors. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 14th ed. New York: McGraw Hill; 2023.
  2. Lorenzo P, Moreno A, Leza JC, Lizasoain I, Moro MA, Portolés A, editors. Velázquez. Farmacología básica y clínica. 20th ed. Madrid: Editorial Médica Panamericana; 2025.
  3. Kenakin TP. Pharmacology in Drug Discovery and Development: Understanding Drug Response. 3rd ed. London: Academic Press; 2024.
  4. Derendorf H, Schmidt S. Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications. 5th ed. Philadelphia: Wolters Kluwer; 2019.
  5. Mitchell PJ. Experimental Design and Statistical Analysis for Pharmacology and the Biomedical Sciences. Hoboken: Wiley-Blackwell; 2022.
  6. Faqi AS, editor. A Comprehensive Guide to Toxicology in Nonclinical Drug Development. 3rd ed. London: Academic Press/Elsevier; 2024.


2. Nonclinical development, safety pharmacology, toxicology and GLP

  1. European Medicines Agency. ICH M3(R2): Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals [Internet]. Amsterdam: EMA; 2013 [cited 2026 Jun 29].
  2. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m3r2-non-clinical-safety-studies-conduct-human-clinical-trials-and-marketing-authorisation-pharmaceuticals-step-5_en.pdf
  3. European Medicines Agency. ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals [Internet]. Amsterdam: EMA; 2000 [cited 2026 Jun 29].
  4. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-7-safety-pharmacology-studies-human-pharmaceuticals-step-5_en.pdf
  5. European Medicines Agency. ICH S7B: Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals [Internet]. Amsterdam: EMA; 2005 [cited 2026 Jun 29].
  6. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-7-b-nonclinical-evaluation-potential-delayed-ventricular-repolarization-qt-interval-prolongation-human-pharmaceuticals-step-5_en.pdf
  7. European Medicines Agency. ICH E14/S7B: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Questions and Answers, Step 5 [Internet]. Amsterdam: EMA; 2022 [cited 2026 Jun 29].
  8. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e14s7b-clinical-and-nonclinical-evaluation-qtqtc-interval-prolongation-and-proarrhythmic-potential-questions-and-answers-step-5_en.pdf
  9. European Medicines Agency. Guideline on Strategies to Identify and Mitigate Risks for First-in-Human and Early Clinical Trials with Investigational Medicinal Products. Revision 1 [Internet]. Amsterdam: EMA; 2017 [cited 2026 Jun 29].
  10. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-and-mitigate-risks-first-human-and-early-clinical-trials-investigational-medicinal-products-revision-1_en.pdf
  11. European Medicines Agency. ICH M10: Bioanalytical Method Validation and Study Sample Analysis [Internet]. Amsterdam: EMA; 2022 [cited 2026 Jun 29].
  12. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m10-bioanalytical-method-validation-step-5_en.pdf
  13. Organisation for Economic Co-operation and Development. OECD Principles on Good Laboratory Practice [Internet]. Paris: OECD; 1998 [cited 2026 Jun 29].
  14. Available from: https://www.oecd.org/content/dam/oecd/en/publications/reports/1998/01/oecd-principles-on-good-laboratory-practice_g1gh32e8/9789264078536-en.pdf
  15. Organisation for Economic Co-operation and Development. OECD Guidelines for the Testing of Chemicals [Internet]. Paris: OECD; [cited 2026 Jun 29].
  16. Available from: https://www.oecd.org/en/topics/sub-issues/testing-of-chemicals/test-guidelines.html


3. Animal models, welfare, the 3Rs and experimental design quality

  1. European Parliament, Council of the European Union. Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes [Internet]. Brussels: European Union; 2010 [cited 2026 Jun 29].
  2. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32010L0063
  3. Ministerio de la Presidencia. Real Decreto 53/2013, de 1 de febrero, por el que se establecen las normas básicas aplicables para la protección de los animales utilizados en experimentación y otros fines científicos, incluyendo la docencia [Internet]. Madrid: Boletín Oficial del Estado; 2013 [consolidated text; cited 2026 Jun 29].
  4. Available from: https://www.boe.es/buscar/pdf/2013/BOE-A-2013-1337-consolidado.pdf
  5. National Research Council. Guide for the Care and Use of Laboratory Animals. 8th ed. Washington, DC: National Academies Press; 2011.
  6. Available from: https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf
  7. Smith AJ, Clutton RE, Lilley E, Hansen KEA, Brattelid T. PREPARE: guidelines for planning animal research and testing. Lab Anim. 2018;52(2):135-141.
  8. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC5862319/
  9. Percie du Sert N, Hurst V, Ahluwalia A, Alam S, Avey MT, Baker M, et al. The ARRIVE guidelines 2.0: updated guidelines for reporting animal research. PLoS Biol. 2020;18(7).
  10. Available from: https://arriveguidelines.org/sites/arrive/files/documents/ARRIVE%20guidelines%202.0%20-%20English.pdf
  11. National Centre for the Replacement, Refinement and Reduction of Animals in Research. Experimental Design Assistant (EDA) [Internet]. London: NC3Rs; [cited 2026 Jun 29].
  12. Available from: https://eda.nc3rs.org.uk/


4. Open resources for mouse models, phenotyping and new methodologies

  1. International Mouse Phenotyping Consortium. International Mouse Phenotyping Consortium (IMPC) [Internet]. [cited 2026 Jun 29].
  2. Available from: https://www.mousephenotype.org/
  3. Mouse Genome Informatics. MGI — Mouse Genome Informatics [Internet]. Bar Harbor, ME: The Jackson Laboratory; [cited 2026 Jun 29].
  4. Available from: https://www.informatics.jax.org/
  5. European Medicines Agency. Regulatory Acceptance of New Approach Methodologies (NAMs) to Reduce Animal Use in Testing [Internet]. Amsterdam: EMA; [cited 2026 Jun 29].
  6. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing/regulatory-acceptance-new-approach-methodologies-nams-reduce-animal-use-testing
  7. U.S. Food and Drug Administration. Roadmap to Reducing Animal Testing in Preclinical Safety Studies [Internet]. Silver Spring, MD: FDA; 2025 [cited 2026 Jun 29].
  8. Available from: https://www.fda.gov/files/newsroom/published/roadmap_to_reducing_animal_testing_in_preclinical_safety_studies.pdf


Software

No special software is required.

Course groups and languages

The information provided is provisional until November 30. After this date, you will be able to consult the language of each group through this link. To access the information, you will need to enter the course CODE

Type of teaching Group Language Semester Shift
(PLABm) Practical laboratories (master) 1 Catalan/Spanish first semester afternoon
(TEm) Theory (master) 101 Catalan/Spanish first semester afternoon
(PAULm) Classroom practices (master) 101 Catalan/Spanish first semester afternoon