NONMEM Intermediate Workshop

NONMEM Intermediate Workshop: New features and advanced methods for model building and evaluation in NONMEM VI San Francisco, CA March 17-19, 2008 Overview: The Center for Drug Development Science (CDDS) is happy to announce the NONMEM Intermediate Workshop co-sponsored with the pharmacometrics group at Uppsala University. The Uppsala group has been involved in developing NONMEM models and methodology for over fifteen years. During the last decade they have been involved in the testing and evaluation of NONMEM VI as it has been developed and several research projects have focused on new functionality in NONMEM VI. In parallel, diagnostics for model building have been developed, evaluated and integrated into NONMEM VI-adapted versions of the programs Perl-speaks-NONMEM (PsN) and Xpose 4 (described below). In this course the Uppsala group will present some of the most exciting new features of NONMEM VI and how these tools can be used in the development and evaluation of non-linear mixed effects models. Agenda (3 full days): The course will last for 3 days and consists of both lectures and hands-on computer exercises. Participants will use NONMEM VI, PsN and Xpose 4. PsN and Xpose 4 are freeware and may be installed on participants' computers for use after the course. In addition to the agenda below consultation sessions will be offered during each day of the course. Day 1: Model building and diagnostics using NONMEM VI with PsN and XPOSE 4 - Introduction to new features of NONMEM VI - Improved model building and diagnostics using PsN and XPOSE 4 - Automation of NONMEM VI runs - Introduction to diagnostics for NONMEM VI runs - Shrinkage and Empirical Bayes estimates based diagnostics - Simulation based reference diagnostics - Hands-on computer exercises with NONMEM VI, PsN and Xpose Day 2: Model building and diagnostics using NONMEM VI with PsN and XPOSE 4 - Conditional weighted residuals - Bootstrapping - Case deletion diagnostics - Visual and numerical predictive checks - Hands-on computer exercises with NONMEM VI, PsN and Xpose Day 3: Advanced methods in NONMEM VI - The use of prior information on parameter values in NONMEM evaluations - Using nonparametric parameter estimation in model building using NONMEM VI - Simultaneous modeling of continuous and categorical data - Handling data below the limit of quantification (BLQ) - Hands-on computer exercises with NONMEM VI, PsN and Xpose Prerequisite: Having used NONMEM with an understanding of population PK-PD modeling and/or having attended a NONMEM basic workshop Instructors: Prof. Mats Karlsson Mats Karlsson is professor of Pharmacometrics at Uppsala University, Sweden where he leads a research group of about twenty modelers. He received his PhD in pharmacokinetics from this university in 1989 and has been a research fellow at University of Glasgow and University of California, San Francisco, and a visiting professor at Georgetown University, Washington DC. He has received the Giorgio Segre Prize from EUFEPS and is editor for the Journal of Pharmacokinetics and Pharmacodynamics. His research interests focus on methodological aspects of non-linear mixed effects model building and applied PKPD modeling. He has published over one hundred original research articles in the area of PK and PKPD. Dr. Andrew Hooker Andrew Hooker is an assistant professor of pharmacometrics at Uppsala University, Sweden. Andrew received his PhD in Bioengineering from the University of Washington, Seattle, USA in 2003, and then moved to Sweden as a Pfizer post-doctoral fellow at Uppsala University. His research focuses on methodological problems associated with building and evaluating pharmacometric models as well as optimal experimental design. Andrew is a primary developer of both Xpose 4 and the optimal design program PopED. Rada Savic Rada Savic joined the Pharmacometric research group at Uppsala University, Sweden in 2003 after receiving her pharmacist degree from University of Belgrade, Serbia. Since then, she has been actively working on evaluating new features of NONMEM VI. Her research interests focus on nonparametric methods for population analysis, improved diagnostics for NONMEM VI and development of new absorption models. Details: The course will emphasize hands on training, with the participants working on their own computers. All programs will run from an USB memory-stick and participants will not be required to install any programs on their computer. NOTE: All participants must bring their own laptops. Xpose 4 is a model building aid for population analysis using NONMEM. Xpose produces various plots and analyses to facilitate data set checkout, goodness-of-fit analysis, model exploration and visualization, model diagnostics, candidate covariate identification and model comparison. Xpose 4 is written in the programming language R with a modular and object oriented design and allows for integration into nearly any model building platform. New functionality in Xpose 4 allows the user to create simulation based reference diagnostics, compute the conditional weighted residuals and modify standard Xpose graphics to create publication quality figures. Xpose 4 also makes use of the new features in NONMEM VI including the visualization of non-parametric parameter distributions and individual objective function contributions. Xpose is freely available at xpose.sf.net. Perl-speaks-NONMEM (PsN) is a collection of Perl modules and programs aiding in the development of non-linear mixed effect models using NONMEM. The functionality ranges from simpler tasks such as parameter estimate extraction from output files, data file sub setting and resampling, to advanced computer-intensive statistical methods. PsN includes both stand-alone tools as well as development libraries for method developers. PsN is freely available at psn.sf.net. Workshop Organizing Committee: Julie Nelson, CDDS-UCSF, Washington DC: [EMAIL PROTECTED] Howard Lee, CDDS-UCSF, Washington DC: [EMAIL PROTECTED] Nancy Sambol, CDDS-UCSF, San Francisco: [EMAIL PROTECTED] Registration: Registration Fees: Industry: $2,300 --- Reduced fees for Academic/Gov't: $1,600 Fees include: syllabus, morning and afternoon refreshment breaks, lunches plus an evening reception. ==> Attendance is limited to 50, so prospective participants are encouraged to register well in advance. ==> Number of reduced fees for Academics and students is limited to a total of 8. ==> Registration and academic fees will be offered on the basis of first come, first served Register online at: www.123signup.com/register?id=xrdrf (more info about hotels in the area can be found on this website by clicking on the "more info" tag) Andrew Hooker, Ph.D. Assistant Professor of Pharmacometrics Div. of Pharmacokinetics and Drug Therapy Dept. of Pharmaceutical Biosciences Uppsala University Box 591, 751 24, Uppsala, Sweden Tel: +46 18 471 4355 http://www.farmbio.uu.se/research.php?avd=5 www.farmbio.uu.se/research.php?avd=5