Degree | Type | Year | Semester |
---|---|---|---|
4311309 Pharmacology | OB | 0 | 1 |
You can check it through this link. To consult the language you will need to enter the CODE of the subject. Please note that this information is provisional until 30 November 2023.
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, .
Apply basic pharmacological knowledge to drug development optimization (R+D) and clinical use, and expand knowledge to help understand their clinical use.
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.
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.
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.
Title | Hours | ECTS | Learning Outcomes |
---|---|---|---|
Type: Directed | |||
Clinical cases seminars | 5 | 0.2 | 1, 2, 4, 5, 6, 7, 8, 9 |
Practice in class | 21 | 0.84 | 1, 2, 4, 5, 6, 7, 8, 9 |
Theory | 66 | 2.64 | 1, 2, 4, 5, 6, 7, 8, 9 |
Type: Supervised | |||
Work supervision/evaluation | 24 | 0.96 | 1, 2, 4, 5, 6, 7, 8, 9 |
scheduled tutoring | 4 | 0.16 | 1, 2, 4, 5, 6, 7, 8, 9 |
unscheduled tutoring | 4 | 0.16 | 1, 2, 4, 5, 6, 7, 8, 9 |
Type: Autonomous | |||
Study, tasks | 172 | 6.88 | 1, 2, 3, 4, 5, 6, 7, 8, 9 |
The note of the module is the arithmetic mean of the notes of the materials that compose it.
Title | Weighting | Hours | ECTS | Learning Outcomes |
---|---|---|---|---|
Studying, performing tasks | 35% | 0 | 0 | 1, 2, 3, 4, 5, 7, 8 |
Test. Written questionary | 15% | 2 | 0.08 | 1, 2, 3, 4, 9 |
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, 5, 7, 8 |
- Cell biology protocols – 2006 / Harris R et al / 978-0-470-84758-9
- Standards of mouse model phenotyping – 2006 / Hrabé de Angelis, Martin / 978-3-527-31031-9
- Fundamentos de las técnicas de biología molecular – 2006 / Tagu et al / 978-84-200-1067-0
- An introduction to molecular biotechnology: from molecular biological fundamentals to methods and applicaions in modern biotechnology – 2006 / Wink M. / 978-3-527-31412-6
- In vivo cellular and molecular imaging – 2005 / Ahrens E / 8978-0-12-153170-6
- Biología celular y molecular: conceptos y experimentos - 2005 / Karp G. et al / 978-970-10-5376-8
- The mouse in biomedical research - 2007 / Fox j. et al
- Cell Biology: a laboratory handbook - 2005 / Celis JE
- Medical methods handbook - 2005 / Walker JM et a
- A guide to methods in the biomedical sciences – 2005 / Corley R (Springer) / 0-387-22845-6
- Discovering Statistics Using IBM SPSS Statistics, 2013. By Andy Field
- Statistical Methods in Medical Research Hardcover – December 15, 2001 by Peter Armitage, Geoffrey Berry, J. N. S. Matthews
- Early Drug Development: Strategies and Routes to First-in-Human Trials. Aug 9, 2010 by Mitchell N. Caye
- Theory of Drug Development (Chapman & Hall/CRC Biostatistics Series)Oct 24, 2013 by Eric B. Holmgren
- A Comprehensive Guide to Toxicology in Preclinical Drug DevelopmentNov 16, 2012 by Ali S. Faqi
- Development of FDA-Regulated Medical Products: A Translational Approach, Second EditionFeb 22, 2012 by Elaine Whitmore
- Laporte J-R. La evaluación de los efectos de los medicamentos documento. Laporte J-R. Principios Básicos de investigación clínica. Barcelona: AstraZeneca; 2001: 1-7.
http://www.icf.uab.cat/ca/pdf/publicacions/pbic/Cap-1.pdf
- Laporte J-R, Tognoni G. Estudios de utilización de medicamentos y de farmacovigilancia. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 1-24.
http://www.icf.uab.cat/ca/pdf/publicacions/pem/cap1.pdf
- Laporte J-R. Estrapolación de los resultados de ensayos clínicos a la práctica habitual. Laporte J-R. Principios Básicos de investigación clínica. Barcelona: AstraZeneca; 2001: 61-78.
http://www.icf.uab.cat/ca/pdf/publicacions/pbic/Cap-5.pdf
- Coggon G, Rose G, Barker DJP. Epidemiology for Uninitiated (fourth edition). BMJ
http://www.bmj.com/about-bmj/resources-readers/publications/epidemiology-uninitiated
- Principios básicos de investigación clínica. Glosario de términos utilizados
http://www.aulaterapeutica.net/moodle/mod/glossary/view.php?id=208
- Grimes DA, Schultz KF. An overview of clinical research: the lay of the land. The Lancet 2002; 358: 57-61.
- Grimes DA, Schultz KF. Cohort studies: marching towards outcomes documento. The Lancet 2002; 359: 341-5.
- Schultz KF, Grimes DA. Case-control studies: research in revers documento. The Lancet 2002; 359: 431-4.
- Abraira V. Medidas del efecto de un tratamiento (I). Notas estadísticas. SEMERGEN 2002; 26: 535-6.
- Abraira V. Medidas del efecto de un tratamiento (II). Notas estadísticas. SEMERGEN 2001; 27: 418-20.
- Evaluación de Tratamientos: ftp://ftp.hrc.es/pub/programas/calcu/evaltrat/evaltrat.htm
- Introducción al ensayo clínico. Documento. Bakke OM, Carné X, García F. Ensayos clínicos con medicamentos. Fundamentos básicos, metodología y práctica. Ediciones Doyma. Barcelona 1994.
- Características del estudio experimental. Documento. Bakke OM, Carné X, García F. Ensayos clínicos con medicamentos. Fundamentos básicos, metodología y práctica.Ediciones Doyma. Barcelona 1994.
- El ensayo clínico controlado: concepto y objetivos. Bakke OM, Carné X, García F. Ensayos clínicos con medicamentos. Fundamentos básicos, metodología y práctica. Ediciones Doyma. Barcelona 1994.
- Laporte J-R. El ensayo clínico controlado. Laporte J-R. Principios Básicos de investigación clínica. Barcelona: AstraZeneca; 2001: 27-54. http://www.icf.uab.es/llibre/pdf/CAP-3.PDF
- Laporte J-R. Metaanálsis de ensayos clíncos. Laporte J-R. Principios Básicos de investigación clínica. Barcelona: AstraZeneca; 2001: 79-92. http://www.icf.uab.es/llibre/pdf/cap-6.pdf
- Egger M, Smith GD, Pillips AN. Meta-analysis. Principles and procedures. BMJ 1997; 315: 1533-7.
- Egger M, Smith GD. Meta-analysis. Potentials and promise. BMJ 1997; 315: 1371-4.
- The Cochrane Collaboration archivo. http://www.cochrane.org/
- Critical Appraisal Skills Programme Español (CASPe) archivo. http://www.redcaspe.org/
- Cochrane Handbook for Systematic Reviews of Interventions. http://www.cochrane.org/handbook
- CONSORT, transparent reporting of trials. http://www.consort-statement.org/resources
- JR Laporte, D Capellà. Mecanismos de producción y diagnóstico clínico de los efectos indeseables producidos por medicamentos. Laporte J-R, Tognoni G. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 95-109. http://www.icf.uab.es/pem/docs/cap5.pdf
- JR Laporte, X Carné. Metodología epidemiológica básica en farmacovigilancia. Laporte J-R, Tognoni G. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 111-130. http://www.icf.uab.es/pem/docs/cap6.pdf
- D Capellà, JR Laporte. La notificación espontánea de reacciones adversas a medicamentos. Laporte J-R, Tognoni G. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 147-169. http://www.icf.uab.es/ca/pdf/publicacions/pem/cap8.pdf
- JR Laporte, X Carné. Estudios de cohortes en farmacovigilancia. Laporte J-R, Tognoni G. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 171-196. http://www.icf.uab.es/pem/docs/cap9.pdf
- S Shapiro, D Kaufman, JR Laporte. La estrategia de casos y controles en farmacovigilancia. Laporte J-R, Tognoni G. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 199-217. http://www.icf.uab.es/pem/docs/cap10.pdf
- Schulz KF, Grimes D. Case-control studies: research in reverse. Lancet 2002: 359: 431–34.
Grimes D, Schulz KF. Bias and causal associations in observational research. Lancet 2002; 359: 248–52.
- Greenhalgh T, Kostopoulou O, Harriee C. Making decisions about benefits and harms of medicines. BMJ 2004;329:47.
- Wood L, Martinez C. The General Practice Research Database. Drug safety 2004; 27; 871-81.
- E Ramirez, A J Carcas, A M Borobia, S H Lei, E Piñana, S Fudio and J Frias. A Pharmacovigilance Program From Laboratory Signals for the Detection and Reporting of Serious Adverse Drug Reactions in Hospitalized Patients. Clinical Pharmacology & Therapeutics 2010; 87:74-86.
- Hans-Georg Eichler, Francesco Pignatti, Bruno Flamion, Hubert Leufkens & Alasdair Breckenridge. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nature Reviews Drug Discovery 2008; 7:818-26.
- Yannick Arimone, Ghada Miremont-Salamé, Françoise Haramburu, Mathieu Molimard, Nicholas Moore, Annie Fourrier-Réglat, and Bernard Bégaud. Inter-expert agreement of seven criteria in causality assessment of adverse drug reactions. Br J Clin Pharmacol. 2007; 64: 482–8.
- Introduction to Drug Utilization Research. 2003 WHO Pharmacological Services.
http://www.whocc.no/filearchive/publications/drug_utilization_research.pdf
- D. Rodríguez, J. Pujol Salud,A. Vallano Ferraz. Describir los resultados de las intervenciones en la práctica clínica. E. Diogène. Guía de investigación clínica para Atención Primaria.
http://w3.icf.uab.es/ficf/es/pub/IAP/GuiaInvestigacionClinicaAP/GICAPcapitulo-7.pdf
- D Capellà, JR Laporte. Métodos aplicados en estudios descriptivos de utilización de medicamentos. Laporte J-R, Tognoni G. Principios de epidemiología del medicamento. Barcelona. Masson-Salvat; 1993: 67-92.
- Drug Utilization Research Group, Europa. http://www.pharmacoepi.org/eurodurg/
- Who Collaborating Centre for Drug Statistics Methodology. http://www.whocc.no/atc_ddd_index/
If needed (Teams)