Variability and uncertainty: interpretation and usage of pharmacometric simulations and intervals
1Clinical Pharmacology and pharmacometrics, Janssen Research & Development, LLC, 1400 McKean Road, 19477, Spring House, PA, PO Box 776, USA. CHu25@its.jnj.com.
Abstract:
Variability and estimation uncertainty are important sources of variation in pharmacometric simulations. Different combinations of uncertainty and the variability components lead to a variety types of simulation intervals, and many realized and unrealized confusions exist among pharmacometricians on their interpretation and usage. This commentary aims to clarify some of the important underlying concepts and provide a convenient guideline on pharmacometric simulation conduct and interpretation.
Related Concept Videos
Analysis of Population Pharmacokinetic Data
Pharmacokinetic Models: Overview
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
Fundamental Mathematical Principles in Pharmacokinetics: Mathematical Expressions and Units
One significant application of mathematics in pharmacokinetics is the characterization of drug distribution through the volume of distribution...
Pharmacokinetic Models: Comparison and Selection Criterion
Physiological models take a detailed approach by considering specific molecular processes. They can predict drug distribution, metabolism, and elimination changes, providing a comprehensive understanding of how drugs interact with the body.
Fundamental Mathematical Principles in Pharmacokinetics: Calculus and Graphs
On the other hand, integral calculus focuses on...
Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches
The model approach uses mathematical models to describe changes in drug concentration over time. Pharmacokinetic models help characterize drug behavior in patients, predict drug concentration in the body fluids, calculate optimum dosage regimens, and evaluate the risk of toxicity. However, ensuring that the model fits the experimental data accurately...


