Assessing goodness-of-fit for evaluation of dose-proportionality.
dose-proportionality
linear pharmacokinetics
visual predictive checks
Journal
Pharmaceutical statistics
ISSN: 1539-1612
Titre abrégé: Pharm Stat
Pays: England
ID NLM: 101201192
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
04
03
2020
revised:
31
07
2020
accepted:
14
09
2020
pubmed:
17
10
2020
medline:
26
11
2021
entrez:
16
10
2020
Statut:
ppublish
Résumé
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.
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
272-281Subventions
Organisme : Department of Health
ID : SRF-2015-08-001
Pays : United Kingdom
Informations de copyright
© 2020 John Wiley & Sons Ltd.
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