2023
DOI: 10.1002/psp4.13056
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Tutorial on model selection and validation of model input into precision dosing software for model‐informed precision dosing

Zachary L. Taylor,
Ethan A. Poweleit,
Kelli Paice
et al.

Abstract: There has been rising interest in using model‐informed precision dosing to provide personalized medicine to patients at the bedside. This methodology utilizes population pharmacokinetic models, measured drug concentrations from individual patients, pharmacodynamic biomarkers, and Bayesian estimation to estimate pharmacokinetic parameters and predict concentration‐time profiles in individual patients. Using these individualized parameter estimates and simulated drug exposure, dosing recommendations can be gener… Show more

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Cited by 8 publications
(2 citation statements)
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“…2,3 Whereas pharmacometric modeling has been widely accepted as a mainstream tool for development of new treatment in optimizing and selecting one-size-fits-all dose on a population level, its application for optimizing treatment on an individual level is still uncommon. 4,5 Model-informed personalized dosing can be especially useful when a new treatment has a narrow therapeutic window on a population level, 6 but advancing it to routine clinical practice requires overcoming numerous barriers, including methodological refinements 7,8 and providing robust evidence to demonstrate improved patient outcomes. 9 Fazpilodemab (BFKB8488A) is a full-length, humanized bispecific IgG1 antibody that selectively targets and activates Klotho β and fibroblast growth factor receptor 1c receptor complex, 10 and was being developed by Genentech for the treatment of nonalcoholic steatohepatitis (NASH).…”
Section: Introductionmentioning
confidence: 99%
See 1 more Smart Citation
“…2,3 Whereas pharmacometric modeling has been widely accepted as a mainstream tool for development of new treatment in optimizing and selecting one-size-fits-all dose on a population level, its application for optimizing treatment on an individual level is still uncommon. 4,5 Model-informed personalized dosing can be especially useful when a new treatment has a narrow therapeutic window on a population level, 6 but advancing it to routine clinical practice requires overcoming numerous barriers, including methodological refinements 7,8 and providing robust evidence to demonstrate improved patient outcomes. 9 Fazpilodemab (BFKB8488A) is a full-length, humanized bispecific IgG1 antibody that selectively targets and activates Klotho β and fibroblast growth factor receptor 1c receptor complex, 10 and was being developed by Genentech for the treatment of nonalcoholic steatohepatitis (NASH).…”
Section: Introductionmentioning
confidence: 99%
“… 2 , 3 Whereas pharmacometric modeling has been widely accepted as a mainstream tool for development of new treatment in optimizing and selecting one‐size‐fits‐all dose on a population level, its application for optimizing treatment on an individual level is still uncommon. 4 , 5 Model‐informed personalized dosing can be especially useful when a new treatment has a narrow therapeutic window on a population level, 6 but advancing it to routine clinical practice requires overcoming numerous barriers, including methodological refinements 7 , 8 and providing robust evidence to demonstrate improved patient outcomes. 9 …”
Section: Introductionmentioning
confidence: 99%