PK/PD studies should be designed in such a way that the model parameters will be estimated with adequate precision and bias. This can be assessed by simulation, but depending on the study and model(s) involved, it can be impractical to evaluate many combinations of design variables. Optimal design tools allow us to quickly evaluate designs and even search over a design space for the best possible design.
In this webinar (recorded on June 8, 2020), we will introduce basic concepts of optimal design, and then present examples of how to inform PK sampling time selection using the R packages PopED and mrgsolve.
This webinar is part of Metrum Research Group’s Cellar Office OPen-EDUcation in Pharmacometrics (“COOPED UP”) events, which feature a range of topics, discussed in vignette formats, to share with our community the same training and development in which our staff routinely engages.
R code from this course can be found at https://github.com/metrumresearchgroup/optimal-design
This course was delivered at the PAGE 2018 meeting in Montreux, Switzerland on June 2, 2018.
This workshop provides a guided hands-on experience in the use of the R package mrgsolve. mrgsolve is a free, open source, validated R package to facilitate simulation from hierarchical, ODE-based PK/PD and systems pharmacology models frequently employed in pharmaceutical research and development programs. You will code, execute, and summarize PK, PK/PD, and systems pharmacology model simulations using mrgsolve and R. Through many examples, you will learn to implement model-based simulations to help address questions at a variety of stages of a development program.
MI212 covers intermediate through advanced-level population PK-PD modeling and simulation through lecture and hands-on lab sessions. Topics covered include for nonlinear PK models, modeling PK data with BQL records, models for parent-metabolite data, models for plasma and urine PK data, indirect PK-PD models, disease progression models and clinical trial simulations. This course makes extensive use of NONMEM® 7 and R, as well as the MIfuns package.
MI210 provides an extensive overview of topics in population pharmacokinetics and pharmacodynamics, including nonlinear mixed-effects modeling theory and implementation, data formatting requirements, population model development, model evaluation techniques, continuous PK-PD models, Monte Carlo simulation, and best practices. Instruction combines didactic lectures with hands-on exercises using R, MIfuns, and the NONMEM® 7 software.