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Biopharmacy and Pharmacokinetics

Code 13684
Year 3
Semester A1
ECTS Credits 12
Workload PL(30H)/T(30H)/TP(60H)
Scientific area Ciências Farmacêuticas
Entry requirements To be a student of Integrated Master’s Degree in Pharmaceutical Sciences that meets the conditions to attend the 3rd year of the course. Although there are no other special entry requirements, it is suggested to approve the related curricular units taught in previous years of the course.
Learning outcomes To deepen the knowledge of the cycle of drugs in the body, the conditioning factors and their implications on the development and optimizing pharmacotherapy; to learn how to estimate the main pharmacokinetic parameters towards the establishment of dosing regimens. The student should be able to: 1. Discuss the relevance and application of biopharmacy and pharmacokinetics in the development of new drugs. 2. Explain the dynamic nature of the general cycle of drugs in the body. 3. Interpret the concentration-time curves that describe the time course of drug concentration in the body and calculate the corresponding pharmacokinetic parameters. 4. Establish the appropriate dose regimens to achieve therapeutic drug levels. 5. Define the assays to be performed in order to assess the bioavailability and bioequivalence of medicines. 6. Perform practical pharmacokinetic-based studies, in an autonomous way or integrated into multidisciplinary working teams.
Syllabus 1. Biopharmacy and pharmacokinetics in drug development (in silico, in vitro and in vivo assays). 2. General cycle of drugs in the body: LADME 3. Compartmental models. Pharmacokinetics of single doses (intravenous bolus injection, continuous intravenous infusion and extravascular administration). Concentration-time curves, estimation and interpretation of kinetic parameters. 4. Kinetics of multiple doses. Concentration-time curves and kinetic parameters at steady-state. 5. Nonlinear pharmacokinetics. Michaelis-Menten kinetics. Chronopharmacokinetics, induction and inhibition. 6. Pharmacokinetic-pharmacodynamic modelling (Emax and sigmoid Emax model). 7. Therapeutic drug monitoring. Pharmacokinetics in special populations (newborns, children, the elderly, renal and hepatic failure, obesity, etc). Pharmacokinetics of subpopulations and Bayesian regression. 8. Bioavailability and bioequivalence. Guideline of bioequivalence of the European Medicines Agency. 9. Bioanalytical methods.
Main Bibliography - T.N. Tozer and M. Rowland (2006); Introduction to Pharmacokinetics and Pharmacodynamics. 1st Ed., Lippincott Williams & Wilkins. - L. Sargel, S. Wu-Pong and A. Yu (2005); Applied Biopharmaceutics & Pharmacokinetics. 5th Ed., McGrawHill. - M. Rowland and T.N. Tozer (1995); Clinical Pharmacokinetics: Concepts and Applications. 3rd Ed., Lippincott Williams & Wilkins. - EMA Scientific Guidelines for Human Medicinal Products (Non-Clinical Guidelines and Clinical Guidelines) - Multiple scientific papers
Teaching Methodologies and Assessment Criteria The pedagogic activity takes place in a face-to-face tutorial system, in which the learning process is centered in the student. This approach encourages an active student participation in the learning process, allowing the development of reasoning and communication skills, and the discussion and integration of the contents underlying the learning objectives defined in each pedagogic unit (UP1 to UP4). Learning activities also include discussion and resolution of practical problems in group, simulating real cases of the professional intervention. Assessment – Methods and criteria: 1. Continuous (TP) and periodic evaluation (T, TP and PL) 2. Final examination Approval requires the final classification of at least 10 values (rounded) in 20 values. It also requires compliance with the conditions for granting frequency (minimum attendance: 70% (T), 80% (TP) and 100% (PL); minimal rating in the teaching-learning period; and presence in all assessment tests].
Language Portuguese. Tutorial support is available in English.
Last updated on: 2021-06-17

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