PhD courses at University of Copenhagen

Introduction to population PKPD modelling
Provider: Faculty of Health and Medical Sciences

Activity no.: 3140-14-00-00
	Enrollment deadline: 19/12/2013

Date and time	06.01.2014, at: 09:00 - 10.01.2014, at: 12:00
Regular seats	14
Course fee	6,360.00 kr.
Lecturers	Mads Kreilgaard
ECTS credits	3.60

Contact person	Marianne Wieslander Jørgensen E-mail address: marianne.joergensen@sund.ku.dk

Enrolment Handling/Course Organiser	PhD administration E-mail address: phdkursus@sund.ku.dk

Aim and content COURSE DESCRIPTION Describing the plasma concentration-time profile (pharmacokinetics, PK) and understanding the quantitative link to pharmacologic/therapeutic response (PKPD) of a drug is paramount for optimising dosage regimens to treat patients and minimise unwanted adverse events. PKPD modelling (also referred to as pharmacometrics or quantitative pharmacology) is the science of developing simplified computer-based models that provide useful mechanistic understanding of the processes involved in drug disposition and corresponding pharmacological/therapeutic effect. Using a population approach enables description of the general population in addition to variability from the average response. This course aims at providing the students with analytical tools to quantify pharmacokinetic (and pharmacodynamic) data from preclinical and clinical studies using industry reference modelling software, NONMEM. The students will obtain basic knowledge about population PKPD modelling and underlying concepts including creation of data sets, model identification and evaluation, goodness of fit, and covariate analysis (e.g. demographics, genetics). The students will be trained with supplied data from previous studies, but they are also encouraged to bring their own PK or PKPD data for modelling. One or two of the students own data set may be selected for group-work model development during the course. Furthermore, this course will provide basic training in model-based simulation of study outcome using different study designs. Course title Introduction to Population Pharmacokinetic/Pharmacodynamic modelling Learning objectives A student who has met the objectives of the course will be able to: a. Understand the key elements of population pharmacokinetic/pharmacodynamics models b. Outline model development strategy for novel data set c. Apply pharmacometric analysis to preclinical and clinical data set containing multiple subjects and potential covariates with response d. Evaluate outcome of a pharmacometric analysis including model fit to observed data Content - Basic population pharmacokinetic-pharmacodynamic concepts - Introduction to non-linear mixed effects ("population") modelling - Hands-on exercises with PKPD modelling using NONMEM software - Presentation of own project and opportunity for model development using own PKPD data set - Classification of different sources of variability including covariates - Simulation of therapeutic pharmacological/outcome Participants/expectations - General knowledge about pharmacokinetics and pharmacodynamics concepts and models. - Basic knowledge in statistics. - Ph.D. students involved in clinical, pharmacological or pharmacokinetics research - Master students signed up for pharmacometric thesis projects A maximum of 16 students are accepted Language English Form Lectures, computer exercises and group work Course director Mads Kreilgaard (Ph.D.), Associate Professor Dept. Drug design & Pharmacology Faculty of Health and Medical Sciences E-mail: mads.kreilgaard@sund.ku.dk Teachers Mads Kreilgaard, KU Trine Meldgaard Lund, KU Kim Kristensen, NovoNordisk Frank Larsen, Lundbeck Peter Thygesen NovoNordisk Course secretary Hanne Haugshøj, E-mail: hha@sund.ku.dk Marianne Wieslander Jørgensen, E-mail: marianne.joergensen@sund.ku.dk Dates January 6th-10th 2014 Course location School of Pharmaceutical Sciences, room D1 & U22