PBPK model reporting template for chemical risk assessment applications.
Documentation
Harmonized report
Pharmacokinetics
Physiologically-based pharmacokinetic (PBPK) model
Regulatory review
Regulatory risk assessment
Regulatory submission
Reporting template
Standardized report
Journal
Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295
Titre abrégé: Regul Toxicol Pharmacol
Pays: Netherlands
ID NLM: 8214983
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
received:
03
03
2020
revised:
18
05
2020
accepted:
28
05
2020
pubmed:
6
6
2020
medline:
26
3
2021
entrez:
6
6
2020
Statut:
ppublish
Résumé
Physiologically-based pharmacokinetic (PBPK) modeling analysis does not stand on its own for regulatory purposes but is a robust tool to support drug/chemical safety assessment. While the development of PBPK models have grown steadily since their emergence, only a handful of models have been accepted to support regulatory purposes due to obstacles such as the lack of a standardized template for reporting PBPK analysis. Here, we expand the existing guidances designed for pharmaceutical applications by recommending additional elements that are relevant to environmental chemicals. This harmonized reporting template can be adopted and customized by public health agencies receiving PBPK model submission, and it can also serve as general guidance for submitting PBPK-related studies for publication in journals or other modeling sharing purposes. The current effort represents one of several ongoing collaborations among the PBPK modeling and risk assessment communities to promote, when appropriate, incorporating PBPK modeling to characterize the influence of pharmacokinetics on safety decisions made by regulatory agencies.
Identifiants
pubmed: 32502513
pii: S0273-2300(20)30117-3
doi: 10.1016/j.yrtph.2020.104691
pmc: PMC8188465
mid: NIHMS1700380
pii:
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
104691Subventions
Organisme : Intramural CDC HHS
ID : CC999999
Pays : United States
Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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