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    Rights statement: This is the peer reviewed version of the following article: Wolfsegger, MJ, Bauer, A, Labes, D, et al. Assessing goodness‐of‐fit for evaluation of dose‐proportionality. Pharmaceutical Statistics. 2020; 1– 10. https://doi.org/10.1002/pst.2074 which has been published in final form at https://onlinelibrary.wiley.com/doi/10.1002/pst.2074 This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.

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    Embargo ends: 15/10/21

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Assessing goodness-of-fit for evaluation of dose-proportionality

Research output: Contribution to journalJournal articlepeer-review

E-pub ahead of print
  • M.J. Wolfsegger
  • A. Bauer
  • D. Labes
  • H. Schütz
  • R. Vonk
  • B. Lang
  • S. Lehr
  • T.F. Jaki
  • W. Engl
  • M.D. Hale
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<mark>Journal publication date</mark>15/10/2020
<mark>Journal</mark>Pharmaceutical Statistics
Number of pages10
Publication StatusE-pub ahead of print
Early online date15/10/20
<mark>Original language</mark>English

Abstract

For the clinical development of a new drug, the determination of dose-proportionality is an essential part of the pharmacokinetic evaluations, which may provide early indications of non-linear pharmacokinetics and may help to identify sub-populations with divergent clearances. Prior to making any conclusions regarding dose-proportionality, the goodness-of-fit of the model must be assessed to evaluate the model performance. We propose the use of simulation-based visual predictive checks to improve the validity of dose-proportionality conclusions for complex designs. We provide an illustrative example and include a table to facilitate review by regulatory authorities. 

Bibliographic note

This is the peer reviewed version of the following article: Wolfsegger, MJ, Bauer, A, Labes, D, et al. Assessing goodness‐of‐fit for evaluation of dose‐proportionality. Pharmaceutical Statistics. 2020; 1– 10. https://doi.org/10.1002/pst.2074 which has been published in final form at https://onlinelibrary.wiley.com/doi/10.1002/pst.2074 This article may be used for non-commercial purposes in accordance With Wiley Terms and Conditions for self-archiving.