Descripción y contextualización de la asignatura

The application of pharmacokinetic and biopharmaceutical principles in predicting drug plasma levels, as well as understanding how these levels vary over time, is a decisive factor in the success of therapeutic treatment. However, the proper use of serum drug levels continues to be one of the main challenges in clinical practice. Pharmacokinetic principles must be applied rationally to each individual patient, as specific physiological and pathological characteristics can cause the same drug dose to result in effective, subtherapeutic, or toxic levels.



The general objectives of this course are to estimate pharmacokinetic parameters and apply them to the initial design of dosage regimens. In addition, the course aims to interpret blood drug levels and use them to control or adjust dosage regimens (therapeutic drug monitoring).

Convocatoria ordinaria: orientaciones y renuncia

1. Written Examination.

Precise and accurate answers to open-ended questions formulated by the instructors covering the entire course content. Students must demonstrate sufficient and appropriate knowledge of the subject. Graded on a scale from 0 to 10. This exam accounts for 35% of the final grade.

To pass this test, the following requirements must be met:



- No serious conceptual errors.

- A non-zero score on at least 70% of the questions.

- A minimum overall score of 5 points.

In this written exam, spelling and syntax mistakes will be penalized based on their number, with a deduction of 0.1 point per error, up to a maximum deduction of 0.5 points.



2. Computer-Based and Classroom Practical Activities.

Attendance and active participation in practical sessions. Graded from 0 to 5. This component contributes 30% to the final grade.



3. Group Project Presentation and Debate.

Students will give an oral presentation using audiovisual support on a topic related to drug monitoring, selected by the instructors. The presentation should last 10¿15 minutes. This component accounts for 35% of the final grade.

Convocatoria extraordinaria: orientaciones y renuncia

Withdrawal: A student will be considered to have withdrawn from the assessment call if they do not attend the mandatory objective test on the date and time specified on the UPV/EHU website.



For the extraordinary call, the grades obtained through continuous assessment (classroom and computer tasks, and group work/presentation) will be retained.

Temario

Theoretical Program:



Topic 1. Concept and basic principles in pharmacokinetics: ADME processes (Absorption, Distribution, Metabolism, and Elimination).

Topic 2. Principles of modeling in pharmacokinetics: pharmacokinetic models and parameters. Compartmental, non-compartmental, and physiological kinetic models. Pharmacokinetic analysis software.

Topic 3. Compartmental models for describing the time course of plasma drug concentrations following single and multiple doses. Selection of pharmacokinetic models.

Topic 4. Population pharmacokinetics.

Topic 5. Clinical pharmacokinetics: concept and objectives. Importance of pharmacokinetics in optimizing therapy.

Topic 6. Methods for estimating pharmacokinetic parameters in clinical pharmacokinetics.

Topic 7. Therapeutic drug monitoring in clinical practice: concept and rationale, methodology, and benefits.

Topic 8. Pharmacokinetics and dosage adjustment in special situations (I): Physiological factors affecting pharmacokinetics ¿ age, pregnancy, and genetic factors.

Topic 9. Pharmacokinetics and dosage adjustment in special situations (II): Pathological factors affecting pharmacokinetics ¿ renal insufficiency.

Topic 10. Pharmacokinetics and dosage adjustment in special situations (III): Pathological factors affecting pharmacokinetics ¿ hepatic insufficiency.

Topic 11. Therapeutic drug monitoring of digoxin.

Topic 12. Therapeutic drug monitoring of aminoglycosides.

Topic 13. Therapeutic drug monitoring of antiepileptics.

Topic 14. Therapeutic drug monitoring of antiretrovirals.

Topic 15. Therapeutic drug monitoring of biological medicines.



Computer-Based Activities:



- Pharmacokinetic analysis: One-compartment models.

- Pharmacokinetic analysis: Two-compartment models. Selection of pharmacokinetic models.

- Pharmacokinetic analysis: Metabolic elimination following Michaelis-Menten kinetics.

- Pharmacokinetics in special situations: Dosage adjustment.



Classroom Practical Activities and Group Work:



- Presentations followed by debate and discussion of monographic assignments on pharmacokinetics and therapeutic drug monitoring.

- Solving case studies and problems related to course content.

Bibliografía

Bibliografía básica

- Tratado General de Biofarmacia y Farmacocinética. Volumen I: LADME. Análisis farmacocinético. Biodisponibilidad y Bioequivalencia. Doménech J, Martínez Lanao J, Peraire C (eds). Editorial Síntesis. 2013.

- Tratado General de Biofarmacia y Farmacocinética. Volumen II: Vías de administración de fármacos: aspectos biofarmacéuticos. Farmacocinética no lineal y clíncia. Doménech J, Martínez Lanao J, Peraire C (eds). Editorial Síntesis. 2013.

- Biofarmacia y Farmacocinética. Ejercicios y problemas resueltos. A Aguilar, M Caamaño, FM Martín, MC Montejo. 2ª edición. Elsevier, 2014

- Basic Pharmacokinetics and pharmacodynamics. An Integrated textbook and computer simulations. SE. Rosenbaum. Wiley. 2011.

- Tratado general de Biofarmacia y Farmacocinética. Volumen I. LADME. Análisis farmacocinético. Biodisponibilidad y

Bioequivalencia. J. Domenech Berrozpe, J. Martínez Lanao, C. Peraire Guitart. Editorial Síntesis. Madrid, 2013.

- Tratado general de Biofarmacia y Farmacocinética. Volumen II. Vías de adminis-tración de fármacos: aspectos

biofarmacéuticos. Farmacocinética no lineal y clíni-ca. J. Domenech Berrozpe, J. Martínez Lanao, C. Peraire Guitart.

Editorial Síntesis. Madrid, 2013.

- Biofarmacia y Farmacocinética. Ejercicios y problemas resueltos. A. Aguilar, M. Caamaño, F. Martín, M.C. Montejo. Ed.

Elsevier. 2ª edición. Madrid, 2014.

- Basic Pharmacokinetics and Pharmacodynamics: an integrated textbook and computer simulations. 2ª Edición. S.E.

Rosenbaum. Ed. John Wiley & Sons, Inc. Hobo-ken, Nueva Jersey, 2017.

- Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications. Malcolm Rowland, Thomas N. Tozer.

Lippincott, Williams & Wilkins 4th edition. Filadel-fia, 2020.

- Applied Biopharmaceutics and Pharmacokinetics. Leon Shargel, Andrew B. C. Yu. McGraw-Hill Education. 7th edition.

EEUU, 2015.

- Fundamentos de farmacología básica y clínica. 3º ed. Ruz Gayo M, Fernéndez Alfonso M, Garrido Garrido G (Eds.) EDITORIAL MÉDICA PANAMERICANA, S. A. Madrid, 2023

Bibliografía de profundización

- Handbook of basic pharmacokinetics including clinical application. W. Ritchell, G.L. Kearns. 7th Ed. APHA. 2009.



- Applied clinical pharmacokinetics. L. Bauer. Mc Graw-Hill. 2nd Ed. 2008.



- Comparative pharmacokinetic. Principles, techniques and applications. J.E. Riviere. Iowa State University Press. 2nd Ed. 2011.



- Applied pharmacokinetics: principles of therapeutic drug monitoring. Burton M, Shaw L, Schentag JJ, Evans We. 4ª ed. Lippincott William &Wilkins. 2005.



- Clinical pharmacokinetics and pharmacodynamics. Concepts and applications. Rowland m, tozer t. 4ª ed. Lippincott William &Wilkins. 2011.



- Basic clinical pharmacokinetics. Me winter. Lippincott William &Wilkins. 2010.



- Applied biopharmaceutics and pharmacokinetics. L Shargel, Wu-Pong S, Yu ABC. 7ª ed. Mac Graw-Hill.2015.



- Quantitative pharmacology. An introduction to integrative pharmacokinetic-pharmacodynamic analysis. J Gabrielson, S Hjorth. Swedish academy of pharmaceutical sciences. 2012.



- Pharmacokinetic-pharmacodynamic modeling and simulation. P Bonate. Springer. 2nd Ed. 2011.



- Concepts in Clinical Pharmacokinetics. W. J. Spruill, W.E. Wade, J.T. DiPiro, R.A. Blouin, J. M. Pruemer. American Society of Health-System Pharmacists, 6th Edition. 2014.