Visualization and communication of pharmacometric models with berkeley madonna
1Actelion Pharmaceuticals Ltd, Department of Clinical Pharmacology, Allschwil, Switzerland.
Abstract:
Population or other pharmacometric models are a useful means to describe, succinctly, the relationships between drug administration, exposure (concentration), and downstream changes in pharmacodynamic (PD) biomarkers and clinical endpoints, including the mixed effects of patient factors and random interpatient variation (fixed and random effects). However, showing a set of covariate equations to a drug development team is perhaps not the best way to get a message across. Visualization of the consequences of the knowledge encapsulated within the model is the key component. Yet in many instances, it can take hours, perhaps days, to collect ideas from teams, write scripts, and run simulations before presenting the results-by which time they have moved on. How much better, then, to seize the moment and work interactively to decide on a course of action, guided by the model. We exemplify here the visualization of pharmacometric models using the Berkeley Madonna software with a particular focus on interactive sessions. The examples are provided as Supplementary Material.
Related Concept Videos
Pharmacokinetic Models: Overview
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
Pharmacodynamic Models: Overview
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
Model Approaches for Pharmacokinetic Data: Compartment Models
Two primary types of compartment models are recognized: mammillary and catenary. The more...
Analysis of Population Pharmacokinetic Data


