Course catalogue doctoral education - HT17

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Title Individual drug dosage in patient care and during clinical drug development: application of pharmacokinetic/-dynamic concepts
Course number 2625
Program 0-Not part of doctoral programme
Language English
Credits 4.5
Date 2012-10-29 -- 2012-11-16
Responsible KI department Department of Laboratory Medicine
Specific entry requirements
Learning outcomes At the end of the course the student should be able to
-understand and show insights in the need to individualize drug dosage in clinical practice and during drug development based on genetic, environmental, physiological and concomitant drug therapy factors
-understand the needs for individualizing dosage regimens of drugs in clinical practice and in clinical drug development and the possibilities to design such regimens by using pharmacokinetic/dynamic theories and concepts
- design pharmacokinetic/-dynamic studies including sampling schedules for evaluation of drug concentrations and pharmacological and outcome effects to establish individualized dosage regimens to treat for example children, elderly and those with decreased liver or kidney functions or patients with infectious or cardiovascular diseases
-design individualized dosage regimens by practising modelling softwares to evaluate pharmacokinetc/dynamic parameters
-show insights in the principles for population pharmacokinetic/-dynamic modelling using sparse data sampling strategies to individualize dosage regimens
-be able to critically read, present and discuss scientific papers on indvidualizing dosage regimens
-be able to present and discuss own and others research projects related to clinical drug research or clinical drug development
-show documented knowledge on the needs for individualized dosage regimens and demonstrate knowledge on the principles of pharmacokinetics/dynamics to address these needs.
Contents of the course BASIC LECTURES ON VARAIBILITY IN DRUG RESPONSE Genetic, environmental, age, drug-drug interaction and disease factors are reviewed and discussed focusing on clinical practice and clinical drug development. The focus will be on different pharmacotherapeutic areas and clinical situations including treatment of infectious diseases, using established and new anticoagulant drugs and achieving optimal efficacy and safety when treating children, elderly and patients with decreased kidney or liver functions. TOOLS TO OPTIMIZE DRUG DOSAGE The principles of therapeutic drug monitoring, drug information and of pharmacokinetics/dynamics tools are reviewed, discussed and used. LITERATURE STUDIES ON RATIONALE FOR CURRENT DOSING REGIMENS OF SELECTED GROUPS AND PHARMACOTHERAPEUTIC AREAS To summarize and discuss Studies performed to support dosing principles, Quality of studies, Available data in subgroups (males, females, children, impaired renal or hepatic function), Suggestions for supplementary studies LITERATURE STUDIES ON INDIVIDUALIZING DOSING REGIMENS AND USING PHARMACOKINETIC/DYNAMIC TOOLS Read, summarize, discuss and apply INDIVIDUALIZING DOSING REGIMENS BY USING PHARMACOKINETIC CONCEPTS Purpose of modelling, pharmacokinetic variables and their physiological correlates, model selection, compartmental vs. non-compartmental methods, population models, assessment of model performance INVIDIDUALIZED DOSING REGIMENS BY INTEGRATION OF PHARMACOKINETIC/DYNHAMI CONCEPTS Purpose of modelling, pharmacodynamic variables and their physiological correlates, model selection, time dimension in models, assessment of model performance BIOSTATISTICAL TOOLS AND MATHEMATICAL CONCEPTS Graphical presentation of data, types of data (dichotomous, categorical, continuous), logarithms and exponential functions, regression functions (linear, nonlinear, logistic), distribution fitting, parametric and nonparametric statistical tests HANDS-ON TRAINING IN USING SOFTWARES TO DEVELOP INDIVIDUALIZED DOSING REGIMENS Organizing the database, Graphical and statistical methods to explore data, transformation of data setting up aims of modeling, model selection, evaluation of model performance (Confidence intervals for parameters, correlations, AIC), statistical evaluation of results. The focus will be to use Win-Nonlin requiring access to own portable computer. CLINICAL DRUG DEVELOPMENT AND DOSAGE REGIMENS Clinical drug development to optimize dosage regimens are reviewed, discussed and applied including the procedures for registration. The focus will be on a study case of a new drug in the area of HIV/AIDS. PRESENTATION OF OWN PROJECTS Each course participant will shortly present and discuss own research or development project related to cliical drug research and optimizing dosage regimens in clinical practice or for development of new drugs.
Teaching and learning activities Lectures, group work, PK-PD calculations, demonstrations and literature review/seminars. Except for teachers/lecturers the course will have tutors with about 5 students each.
Compulsory elements Lectures, groups work, calculations, demonstrations and seminars are obligatory. If a student fail to participate in all moments it is required that the students document knowledge/understanding and document that he/she has calculated and analyzed data. The course includes 2 weeks of full-time participation following lectures, reviewing and presenting research articles, participating in work-shops, doing practical exercises including using softwares for calculating pharmacokinetic/dynamic parameters to improve drog dosage regimens and finally presenting own research projects. One course week is for preparatory work and for a home-examination of the course contents.
Examination Literature reviews and home examination
Literature and other teaching material 1. Principles of Clinical Pharmacology, Second Edition [Hardcover] by Arthur J. Atkinson Jr. (Editor), Darrell R. Abernethy (Editor), Charles E. Daniels (Editor), Robert Dedrick (Editor), Sanford P. Markey (Editor) 2. Malcolm Rowland, Thomas N Tozer. Clinical Pharmacokinetics and Pharmacodynamics: concepts and pplications. 4th edition. Wolters Kluwer and Lippincott Williams & Wilkins, 2011 3. A First Course in Pharmacokinetics and Biopharmaceutics by David Bourne-available at http://www.boomer.org/pkin/ 4. Prepared course material 5. Literature articles provided and recommended
Number of students 10 - 25
Selection of students Prioirity for PhD students in most relevant areas for the course.
More information Observe that the course is for THREE weeks. ONE week totally is used for preparation before the course and for HOME EXAMINATION AFTER THE COURSE! Two weeks (121105-121116) require PHYSICAL presence at Karolinska Institutet, Clinical Pharmacology, Department of Laboratory Medicine at Karolinska University Hospital Huddinge. The course leaders are: A. MD PhD Markus Jerling, clinical pharmacologist/psychiatrist, with years of experience in clinical pharmacology and in clinical drug development in Sweden, Europe and US and previous course leader for the joint pharmacokinetic/dynamic research course in Kampala in October 2011. Professor Lars L Gustafsson, clinical pharmacologist, at Karolinska Institutet with years of experience in understanding variability in drug response focusing on infectious diseases- in particular malaria and HIV/AIDS. MD PhD Staffan Rosenborg, clinical pharmacologist and specialist in renal medicine, and senior staff at Clinical Pharmacology, Karolinska University Hospital. Interested in pharmacogenetic variablity in drug response and adjusted dosage in patients with decreased kidney function. B. Senior and junior staff at clinical departments at Karolinska University Hospital, specialists from Medical Products Agents and from drug industries will participate as lecturers or instructors. Associate professor Urban Hellgren at Karolinska University Hospital and Dr Per-Olof Kjellström from Karolinska University Hospital/Medical Products Agency. Prior to the course it is recommended to aquire basic knowledge on variability in drug response and aspects on pharmacokinetics and pharmacodynamics. Costs for travel and housing have to be covered by participant/participating home institution. The course should BE OF INTEREST for all reserch students involved in clinical and basic drug research. The clinical topics of the course will be adapted to the background of the students ensuring that the students can contribute with their background and knowledge in how to best understand the needs for individualized dosing regimens. The course will be higly interactive requiring access to own portable computer to be used for exercises and analyzing data using pharmacokinetic/dynamic software to be available during the course period- most likely Winnonlin program. The course particpants are expected to present their own research and thereby getting feed-back irrespective the phase of the studies.
Course directors The course will be given in collaboration with Makerere University, College of Health Sciences with involvement of associate professor Celestino Obua (clinical pharmacologist) and PhD, senior lecturer Muhammad Ntale (specialist in drug analysis).
Earlier evaluation of the course Not available
Course responsible Lars-L Gustafsson
Department of Laboratory Medicine

Lars-L.Gustafsson@ki.se
Contact person -