Overview

The Uppsala Pharmacometrics Group is happy to announce a NONMEM Workshop on Pharmacokinetic-Pharmacodynamic (PKPD) modeling of Continuous and Categorical data tailored for Intermediate and Advanced NONMEM users. The course will present modeling strategies, techniques and implementations for the handling of PK and PD information in population models. PD models for continuous data as well as binary, ordered categorical, count, and (repeated) time to event data will be discussed. The course will also cover the latest methods for evaluation of continuous and categorical PK/PD models.

The course will consist of both lectures and hands-on computer exercises using NONMEM 7, PsN and Xpose 4. Self-instructive material is provided for further studies and exploration of examples within the field. The participants will be provided with a NONMEM library of example code for a wide range of PKPD models applied in different disease areas.

The Uppsala group has been involved in developing NONMEM models and methodology for over twenty years and has extensive experience in development of PKPD models, model building procedures and methods for modeling continuous and categorical data using non-linear mixed-effects modeling in NONMEM. In parallel, informative diagnostics for model building and model evaluation have been developed, evaluated and integrated into the user-friendly software Perl-speaks-NONMEM (PsN) and Xpose 4.

Course Outline (2.5 days)

The course will last for 2.5 days and consists of both lectures and hands-on computer exercises.

Day 1 – Modeling strategies for PKPD models, estimation and diagnostic tools (NONMEM, PsN, Xpose), Placebo and baseline modeling

• Modeling strategies for PKPD data
• Baseline and Biological rhythm models
• Placebo effects and Disease progression models
• Models for delayed drug effects
• Semi-mechanistic models used in different disease areas
• Models integrating PK and PD
• Model building diagnostics for PKPD models
• Introduction to PsN and Xpose
• Hands-on computer exercises with NONMEM 7, PsN and Xpose

Day 2 – PKPD modeling for continuous, binary, ordered categorical and time-to-event data

• Models, diagnostics and model building for binary data
• Models, diagnostics and model building for ordered categorical data
• Models, diagnostics and model building for (repeated) time-to-event data
• Hands-on computer exercises with NONMEM 7, PsN and Xpose

Day 3 – PKPD modeling for count data. Combining continuous and categorical measurements.

• Models, diagnostics and model building for count data
• Markov models for categorical data
• Models for a mixture of continuous and categorical data
• Drop-out models
• Hands-on computer exercises with NONMEM 7, PsN and Xpose

Prerequisite

A prerequisite for the course is experience with performing NONMEM analyses or having attended a NONMEM basic workshop.

Instructors

Prof. Mats Karlsson
Prof. Lena Friberg
Assoc. Prof. Andrew Hooker
Prof. Ulrika Simonsson

Computer hardware/software

The course will include hands-on training, with the participants working on their own computers. All programs will run from a USB memory-stick and participants will not be required to install any programs on their computer. All participants must bring their own Windows laptops (virtual machines ok).

Registration fee

Regular fee: €1,500
Student fee: €1,000

Extensive electronic material including lectures, exercises, programs (PsN and Xpose), additional self-study material including hands-on's and solutions. Morning and afternoon refreshments and lunches are included.