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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. 2021; 20: 272– 281. 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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Assessing goodness-of-fit for evaluation of dose-proportionality

Research output: Contribution to Journal/MagazineJournal articlepeer-review

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Assessing goodness-of-fit for evaluation of dose-proportionality. / Wolfsegger, M.J.; Bauer, A.; Labes, D. et al.
In: Pharmaceutical Statistics, Vol. 20, No. 2, 31.03.2021, p. 272-281.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Wolfsegger, MJ, Bauer, A, Labes, D, Schütz, H, Vonk, R, Lang, B, Lehr, S, Jaki, TF, Engl, W & Hale, MD 2021, 'Assessing goodness-of-fit for evaluation of dose-proportionality', Pharmaceutical Statistics, vol. 20, no. 2, pp. 272-281. https://doi.org/10.1002/pst.2074

APA

Wolfsegger, M. J., Bauer, A., Labes, D., Schütz, H., Vonk, R., Lang, B., Lehr, S., Jaki, T. F., Engl, W., & Hale, M. D. (2021). Assessing goodness-of-fit for evaluation of dose-proportionality. Pharmaceutical Statistics, 20(2), 272-281. https://doi.org/10.1002/pst.2074

Vancouver

Wolfsegger MJ, Bauer A, Labes D, Schütz H, Vonk R, Lang B et al. Assessing goodness-of-fit for evaluation of dose-proportionality. Pharmaceutical Statistics. 2021 Mar 31;20(2):272-281. Epub 2020 Oct 15. doi: 10.1002/pst.2074

Author

Wolfsegger, M.J. ; Bauer, A. ; Labes, D. et al. / Assessing goodness-of-fit for evaluation of dose-proportionality. In: Pharmaceutical Statistics. 2021 ; Vol. 20, No. 2. pp. 272-281.

Bibtex

@article{130a8bb54b9040cb8daf495339bb728b,
title = "Assessing goodness-of-fit for evaluation of dose-proportionality",
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. ",
keywords = "dose-proportionality, linear pharmacokinetics, visual predictive checks",
author = "M.J. Wolfsegger and A. Bauer and D. Labes and H. Sch{\"u}tz and R. Vonk and B. Lang and S. Lehr and T.F. Jaki and W. Engl and M.D. Hale",
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. 2021; 20: 272– 281. 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. ",
year = "2021",
month = mar,
day = "31",
doi = "10.1002/pst.2074",
language = "English",
volume = "20",
pages = "272--281",
journal = "Pharmaceutical Statistics",
issn = "1539-1604",
publisher = "John Wiley and Sons Ltd",
number = "2",

}

RIS

TY - JOUR

T1 - Assessing goodness-of-fit for evaluation of dose-proportionality

AU - Wolfsegger, M.J.

AU - Bauer, A.

AU - Labes, D.

AU - Schütz, H.

AU - Vonk, R.

AU - Lang, B.

AU - Lehr, S.

AU - Jaki, T.F.

AU - Engl, W.

AU - Hale, M.D.

N1 - 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. 2021; 20: 272– 281. 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.

PY - 2021/3/31

Y1 - 2021/3/31

N2 - 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. 

AB - 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. 

KW - dose-proportionality

KW - linear pharmacokinetics

KW - visual predictive checks

U2 - 10.1002/pst.2074

DO - 10.1002/pst.2074

M3 - Journal article

VL - 20

SP - 272

EP - 281

JO - Pharmaceutical Statistics

JF - Pharmaceutical Statistics

SN - 1539-1604

IS - 2

ER -