• The in-depth understanding of the basic pharmacokinetic concepts, processes (absorption, distribution, metabolism, excretion) and basic pharmacokinetic relationships.
• The determination of the different pharmacokinetic parameters and the analysis of their effect on drug concentrations in plasma after single or multiple dosing.
• The aacquiring of skills through solving representative pharmacokinetic exercises on the application of pharmacokinetic principles in clinical practice in order to overcome specific therapeutic problems.
• The assessment of the suitability of dosage regimens and the design of dosage regimens in order to achieve therapeutic concentrations of the drug to the patient.
• The analysis of clinically significant pharmacodynamic and pharmacokinetic drug interactions and how to manage them.
The lectures and tutorials aim to assist pharmacy students in developing their capabilities to: a) assess and predict clinically relevant drug interactions; b) acquire knowledge on how drug delivery outcomes can be strengthened in healthcare; and c) develop practical skills as practitioners in order to improve drug efficacy and safety profiles in clinical practice. In order these targets to be achieved, specific teaching methodologies are applied: 1) lectures focusing on selected pharmacokinetics, pharmacodynamics, pharmacogenomics and personalized medicine concepts; 2) discussions of specific clinical drug interaction case studies within the frame of evidence-based medicine; and 3) tutorials for specific drug dosage scheme data evaluation by implementing the “Simcyp-Population Based Pharmacokinetic Modelling and Simulation» platform (academic license agreement since 2009).
Course Content (Syllabus)
Introduction to the basic concepts of pharmacokinetics. Absorption of drugs. Distribution of drugs. Binding of drugs with plasma proteins and tissues. Clearance of drugs. Pharmacokinetics of rapid intravenous injection (bolus). Pharmacokinetics of intravenous drug infusion. Pharmacokinetics of extravascular drug administration. Multiple dosage regimens. Dosage regimens for patients with impaired kidney function. Pharmacokinetic drug interactions. Pharmacokinetic factors that require individualization of dosage regimens. Drug metabolism. Importance of stereoselectivity in therapeutics. Representative pharmacokinetic exercises for the understanding the effect of various parameters in the pharmacokinetic profiles of drug concentrations in plasma versus time, estimation of various pharmacokinetic parameters, and design of optimal dosage regimens.
Protein binding of drugs, Intestine drug metabolism, Hepatic drug metabolism, Assessment of drug interactions mechanisms, Drug-drug drug-food and drug-herb interactions, Mechanisms involved in the emergence of adverse drug interactions, Pharmacogenomics and adjustment of drug dosage delivery, PK-based drug prescription principles, Pharmacoeconomy issues in drug delivery, Clinical relevance of drug metabolizing enzymes and transporters genetic polymorphism, Individualizing drug delivery dosage schemes in clinical practice, Environmental toxicants and drug delivery. Examples of pharmacokinetic case studies discussed: a)) cerivastatin market removal, b) removal of rofecoxib from the clinical practice ροφεκοξίμπης, c) drug-induced QT-elongation and drug cardiotoxicity and d) PK-based methodological improvements applied upon indinavir new drug development.