The Clinical Utility of Pharmacometric Models

Document Type

Article

Publication Date

7-2018

Abstract

Pharmacometric models are powerful tools that can be used for a variety of purposes in clinical pharmacology, drug development and dose individualization. Lewis Sheiner famously described the process of learning versus confirming in the setting of drug development 1 and as applied to pharmacometrics. An example of learning is the quantitative description of the human coagulation network 2 which was then paired with prospective clinical data 3 to confirm the predictive performance of this model. Additionally, models can be used to help design clinical trials via simulation 4 and even provide information for the labelling of drug products 5. The clinically relevant goal is to determine if and how doses can be individualized.

DOI

10.1111/bcp.13603

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