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Applied Pharmacology

Code: 42358
Credits: 12
2026/2027
Degree programme Type Course
Pharmacology OB 0

Contact lecturer

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

Teaching staff

Margarita Arboix Arzo
Marcel Jimenez Farrerons
Alberto Marco Valle
Fernando de Mora Pérez
Ignacio José Gich Saladich
Rosa Maria Morros Pedros
Rubén Foj Ibars
Mónica Sabate Gallego
Judit Riera Arnau
Rosa María Antonijoan Arbos
Maria Antonieta Agusti Escasany
Inmaculada Fuentes Camps
Maria Gloria Cereza Garcia

Teaching staff (external to UAB)

David Sabaté

Group languages

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

Prerequisites

In order to correctly follow the module, students need to have previous knowledge of pharmacology, related to the mechanisms of action of drugs as well as the need to carry out specific studies during the development of a molecule as a drug. They are also supposed to have basic knowledge of simple statistical techniques. Most of this knowledge will have been acquired in module 1 of the master's degree itself, and some others should be of general knowledge before initiation of the master's degree. This knowledge is related to statistics, and, they are part of the knowledge gained in the majority of the diplomas, degrees, or bachelor's degrees that give access to the master's degree, .

Objectives

Apply basic pharmacological knowledge to drug development optimization (R+D) and clinical use, and expand knowledge to help understand their clinical use.

Learning outcomes

  1. Desenvolupar habilitats d'autoaprenentatge.
  2. Capacitat d'anàlisi i síntesi.
  3. Desenvolupar un pensament crític i autocrític.
  4. Identify the phases of clinical and pre-clinical development of medicines and describe their characteristics.
  5. Identify how drugs are used in our society and the economic and medical factors that determine the choice of medicines.
  6. Explain the regulatory framework in which medical trials must take place.
  7. Indicate the scientific and technical principles and the objectives that are formulated when applying the most common laboratory techniques for drug-testing.
  8. Describe the methodology used to critically assess studies on drug effectiveness and safety.
  9. Recognise basic statistical concepts and the main tests used that help to interpret pre-clinical and clinical studies with medicines.

Contents

a) Life cycle of a drug. Origin and obtaining of medicines: chemical synthesis, biotechnological processes and extraction from natural sources. Pharmaceutical and galvanic technology. Pre-clinical development: activity-structure, basic and safety pharmacology, basic and special toxicology. Clinical development: different phases of the clinical trial. Post-authorization and pharmacovigilance.


b) Legislation and registration of medicines in Spain, the European Union and other countries. Guides. Special medicines for rare diseases and/or special populations (paediatrics), medicines of biotechnological origin. The case of sanitary products. Agents involved in drug development: administration, industry, service companies (CRO), research centers and hospitals.


c) General introduction to classic and current pharmacology techniques. In vivo systems to evaluate the action and effect of drugs: induction of models, concepts of knockouts and GMOs. In vitro systems for drug evaluation: cell culture, FACS, MACS, organ bath, electrophysiology (patch clam). Processing of histological samples and microscopy (optical, confocal, etc.). In vivo and in vitro techniques for the study of the release of neurotransmitters: indirect functional studies and others (synaptosomes, miniprisms, microdialysis). General methods of determination and quantification of molecules: colorimetry, spectrophotometry, fluorotry, chromatograph, mass spectrometry, etc. Protein determination: bioassays, immunoassays (ELISA/RIA), western blot, immunocito(histo)chemical, flow cytometry. Determination of nucleotides: RT-PCR, northern blot, in situ hybridization / sequencing. Measurement of pharmacological receptors: radioligandos fixation techniques, biochemical techniques of application in the study of receptors. Pharmacokinetic techniques: pharmacological treatment and sample collection, drug-protein binding, extraction, dose-response curve. Biotechnological processes in the production of biopharmaceuticals: recombinant DNA, monoclonal antibodies, etc.


d) General concepts of epidemiology. Critical evaluation of clinical trials. Types of epidemiological studies. Evaluation of safety studies and pharmacovigilance. Meta-analysis. Drug use studies.


e) Descriptive statistics. Inferential statistics. Association – correlation. Imputation of causation. Bivariant analysis. Sample size. Sensitivity, specificity and ROC curves.

Learning activities and methodology

Title Hours ECTS Learning outcomes
scheduled tutoring 4 0.16 2, 3, 4, 5, 6, 7, 8, 9
Clinical cases seminars 5 0.2 2, 3, 4, 5, 6, 7, 8, 9
Practice in class 21 0.84 2, 3, 4, 5, 6, 7, 8, 9
Work supervision/evaluation 24 0.96 2, 3, 4, 5, 6, 7, 8, 9
Theory 66 2.64 2, 3, 4, 5, 6, 7, 8, 9
Study, tasks 172 6.88 1, 2, 3, 4, 5, 6, 7, 8, 9
unscheduled tutoring 4 0.16 2, 3, 4, 5, 6, 7, 8, 9

Different methodologies will be used to encourage the interaction of students with each other, with professionals from different fields, as well as teamwork and personnel work.


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
class follow-up 20% 0 0 1, 2, 3, 4, 5, 6, 7, 8, 9
works exhibition 30% 2 0.08 1, 2, 3, 4, 6, 7, 8
Test. Written questionary 15% 2 0.08 1, 2, 3, 8, 9
Studying, performing tasks 35% 0 0 1, 2, 3, 4, 6, 7, 8

The note of the module is the arithmetic mean of the notes of the materials 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. Clinical development, regulation and good clinical practice

  1. European Medicines Agency. ICH E6(R3) Guideline for Good Clinical Practice (GCP): Step 5 [Internet]. Amsterdam: EMA; 2025 [cited 2026 Jun 29].
  2. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r3-guideline-good-clinical-practice-gcp-step-5_en.pdf
  3. European Parliament, Council of the European Union. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [Internet]. Brussels: European Union; 2014 [cited 2026 Jun 29].
  4. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536
  5. European Medicines Agency. Clinical Trials Information System (CTIS) Sponsor Handbook [Internet]. Amsterdam: EMA; 2026 [cited 2026 Jun 29].
  6. Available from: https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_en.pdf
  7. 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].
  8. 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
  9. European Medicines Agency. ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials [Internet]. Amsterdam: EMA; 2020 [cited 2026 Jun 29].
  10. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e9-r1-addendum-estimands-and-sensitivity-analysis-clinical-trials-guideline-statistical-principles-clinical-trials-step-5_en.pdf


2. Clinical trials, protocols and evidence synthesis

  1. Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025;389. doi:10.1136/bmj-2024-081477.
  2. Available from: https://www.bmj.com/content/bmj/389/bmj-2024-081477.full.pdf
  3. Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025;389. doi:10.1136/bmj-2024-081123.
  4. Available from: https://www.bmj.com/content/bmj/389/bmj-2024-081123.full.pdf
  5. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372. doi:10.1136/bmj.n71.
  6. Available from: https://www.bmj.com/content/bmj/372/bmj.n71.full.pdf
  7. Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al., editors. Cochrane Handbook for Systematic Reviews of Interventions. Version 6.5 [Internet]. London: Cochrane; 2024 [cited 2026 Jun 29].
  8. Available from: https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current


3. Preclinical development, toxicology and animal models

  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. 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).
  4. Available from: https://arriveguidelines.org/sites/arrive/files/documents/ARRIVE%20guidelines%202.0%20-%20English.pdf
  5. Faqi AS, editor. A Comprehensive Guide to Toxicology in Nonclinical Drug Development. 3rd ed. London: Academic Press/Elsevier; 2024.
  6. Publisher record: https://shop.elsevier.com/books/a-comprehensive-guide-to-toxicology-in-nonclinical-drug-development/faqi/978-0-323-85704-8


4. Pharmacovigilance, pharmacoepidemiology and drug utilisation

  1. European Medicines Agency. Good Pharmacovigilance Practices (GVP) [Internet]. Amsterdam: EMA; [cited 2026 Jun 29].
  2. Available from: https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp
  3. Strom BL, Kimmel SE, Hennessy S, editors. Textbook of Pharmacoepidemiology. 3rd ed. Hoboken: Wiley-Blackwell; 2021.
  4. Publisher record: https://www.wiley.com/en-us/Textbook+of+Pharmacoepidemiology%2C+3rd+Edition-p-9781119701071
  5. World Health Organization. Introduction to Drug Utilization Research [Internet]. Oslo: WHO Collaborating Centre for Drug Statistics Methodology; 2003 [cited 2026 Jun 29].
  6. Available from: https://atcddd.fhi.no/filearchive/publications/drug_utilization_research.pdf
  7. WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD Index [Internet]. Oslo: Norwegian Institute of Public Health; [cited 2026 Jun 29].
  8. Available from: https://www.whocc.no/atc_ddd_index/


5. Applied statistics

  1. Field A. Discovering Statistics Using IBM SPSS Statistics. 6th ed. London: SAGE; 2024.
  2. Publisher record: https://collegepublishing.sagepub.com/products/discovering-statistics-using-ibm-spss-statistics-6-285130


Software

No specific 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
(TEm) Theory (master) 101 Catalan/Spanish first semester afternoon
(PAULm) Classroom practices (master) 101 Catalan/Spanish first semester afternoon
(PLABm) Practical laboratories (master) 101 Catalan/Spanish first semester afternoon
(SCCm) Clinical case seminars (master) 101 Catalan/Spanish first semester afternoon