Curricular Unit:			Code:
Biopharmaceutics and Pharmacokinetics			843BFAR
Year:	Level:	Course:	Credits:
4	Master	Pharmaceutical Sciences	5 ects
Learning Period:		Language of Instruction:	Total Hours:
Spring Semester		Portuguese/English	65
Learning Outcomes of the Curricular Unit:
Students should know the different phases of drug development as well as the different phases (ADME) inside the human body. Student must know how to calculate the main pharmacokinetical parameters and determine and adjust posological regimens according to the therapeutical goals. They should recongnize pharmacokinetical and pharmacodinalmical interactions. Students should understand and be able to evaluate bioequivalence studies. Students should be able to adapt posological regimens to special populations.
Syllabus:
I. Fundamental Concepts in Pharmacokinetics. 1.Pharmacokinetics, clinical pharmacokinetics and toxicokinetics. 2. Phases of medicines cycle. 3. Biopharmaceutics and Pharmacokinetics. 4. Phases of the clinical development of a drug. II Drug cycle whithin the body. 1 Drug absorption. 2. Kinetics of distribution and elimination. III –Pharmacokinetical parameters and models. 1-Linear, Non Linear and Compartimental Models. 2. One and multiple dose kinetics.3. Posological charts. 4 Pharmacodinamics (PD) and Pharmacokinetics (PK). of treatments5. PK/PD modelling. 6. Therapeutic monitoring. Interactions. 7. Bioavailability and Bioequivalence. 8. Therapeutic individualization. Drugs in special populations.
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
"Students should know the different phases of drug development as well as the different phases (ADME) inside the human body. Student must know how to calculate the main pharmacokinetical parameters and determine and adjust posological regimens according to the therapeutical goals. . They should recongnize pharmacokinetical and pharmacodinalmical interactions. Students should understand and be able to evaluate bioequivalence studies. Students should be able to adapt posological regimens to special populations.
Teaching Methodologies (Including Evaluation):
Theoretical classes with audiovisual exposition. Pratical classes with exercises on pharmacokinetical parameters determination, modeling and posology charts. Clinical cases analysis. Continuous evaluation by 2 tests with theoretical questions and pratical cases resolution, weighting 50% each
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
The theoretical transmission of the pharmacokinetical fundamentals will allow students do acquire the knowledge that corresponds to the purpose of the curricular unit. The resolution of practical exercises as well as the clinical cases will allow students to integrate and apply their knowledge in an approach to the clinical reality.
Reading:
(1) José Domenech Berrozpe; José Martínez Lanao; Concepción Peraire Guitart (eds.). Tratado General de Biofarmacia y Farmacocinética Vol I e II. Editorial Sìntesis, Madrid, 2013. (2) Shargell L, Yu ABC. Applied Biopharmaceutics and Pharmacokinetics. 5ª ed. Mc Graw-Hill, New York, 2005 Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications - Malcom Rowland, Thomas Tozer - wolters kluwer 2010 Guidelines da Agência Europeia do Medicamento