Taking the leap toward human-specific nonanimal methodologies: The need for harmonizing global policies for microphysiological systems.
Journal
Stem cell reports
ISSN: 2213-6711
Titre abrégé: Stem Cell Reports
Pays: United States
ID NLM: 101611300
Informations de publication
Date de publication:
05 Dec 2023
05 Dec 2023
Historique:
received:
26
08
2023
revised:
20
11
2023
accepted:
20
11
2023
medline:
23
12
2023
pubmed:
23
12
2023
entrez:
22
12
2023
Statut:
aheadofprint
Résumé
With a recent amendment, India joined other countries that have removed the legislative barrier toward the use of human-relevant methods in drug development. Here, global stakeholders weigh in on the urgent need to globally harmonize the guidelines toward the standardization of microphysiological systems. We discuss a possible framework for establishing scientific confidence and regulatory approval of these methods.
Identifiants
pubmed: 38134927
pii: S2213-6711(23)00457-5
doi: 10.1016/j.stemcr.2023.11.008
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests The authors declare no competing interests.