The schedule for the Saturday workshops is described in the course overview.
Sunday (full day): Statistical basis of population modeling. Advanced NONMEM control files and data structures.
Creating a NONMEM data set with R. By Wednesday afternoon, users will have NONMEM and R running
on their laptop computers. Wednesday concludes with a complex pharmacokinetic data set, done as a class,
with multiple covariates. If attendees brought their own data to analyze, then Wednesday's homework is to
prepare the input files for NONMEM, using R or Excel. If attendees did not bring their own data to analyze,
then Wednesday's homework is running examples in their area of interest. The examples cover the entire
curriculum, ranging from simple pharmacokinetic analysis to integrated PK/PD models of
indirect drug effects and target controlled drug administration.
Monday (full day): Model building with NONMEM, including advanced pharmacodynamic
models, variance models, covariate models, simulation, and model diagnostics. The use of PLT tools to
provide CFR 21 Part 11 compliance and traceability is discussed. The afternoon is devoted to users
working with the examples or modeling their own data, with the instructors providing personal guidance.
Tuesday (full day): Building pharmacodynamic models (including modeling binary and
ordered categorical data), model validation, simulation, and power analysis. The afternoon will be
devoted to users working with the examples or their own data.
Wednesday (morning): Advanced modeling concepts, including clinical trial simulation
with NONMEM, power analysis, interoccasion variability, and categorical data analysis.
The PLT Tools workshop on Wednesday afternoon is described in the course overview.