Curriculum

Pharmacokinetics: 1, 2, and 3 compartment mammillary models, including bolus, infusion, absorption, deconvolution analysis of controlled release formulations, and target controlled drug delivery.

Pharmacodynamics: sigmoidal models of drug effect, modeling binary response/no response data, hysteresis, combined PK/PD modeling, modeling indirect drug effects, nonparametric models.

Time Series: Building statistical models with NONMEM is more robust than conventional RMANOVA in assessing time series data. Examples of time series data (pain scores over time) will be discussed.

NONMEM: Setting up data files, control files for PK, PD, and time series ANOVA, running NONMEM, batch processing with NONMEM, interpretation of NONMEM output, diagnostic graphics using PLT Tools.

Model Building: Exploring covariate structures, automated covariate exploration (via PLT Tools), automated documetation of the modeling development steps.

Special: Simulation, power analysis, interoccasion variability, basic application of PLT Tools to running NONMEM, Log Likelihood profiling, Effect size analysis, Bootstrap analysis, Jackknife analysis, project documentation to conform with 21 CFR 11 requirements, automated report generation.

Course attendees must bring their own laptop computers. We recommend that users have Excel installed. All other software is installed on the first day of the course.

Course attendees are encouraged to bring their own data to use in place of the supplied examples, if they have such data sets available to them. About 80% of of attendees bring their own data to analyze with NONMEM.

NONMEM need not be installed on the laptop prior to attending the course. However, all attendees must have a NONMEM license, either personally or through their employer, before attending the course. NONMEM licenses can be obtained from ICON Development Solutions (formerly Globomax Corporation).