A Perspective on Model-Informed IVIVC for Development of Subcutaneous Injectables.
IVIVC
PK
long-acting delivery
multiphysics
simulation
Journal
Pharmaceutical research
ISSN: 1573-904X
Titre abrégé: Pharm Res
Pays: United States
ID NLM: 8406521
Informations de publication
Date de publication:
Jul 2023
Jul 2023
Historique:
received:
27
02
2023
accepted:
19
07
2023
medline:
14
8
2023
pubmed:
31
7
2023
entrez:
31
7
2023
Statut:
ppublish
Résumé
Subcutaneously administered drugs are growing in popularity for both large and small molecule drugs. However, development of these systems - particularly generics - is slowed due to a lack of formal guidance regarding preclinical testing and in vitro - in vivo correlations (IVIVC). Many of these methods, while appropriate for oral drugs, may not be optimized for the complex injection site physiologies, and release rate and absorption mechanisms of subcutaneous drugs. Current limitations for formulation design and IVIVC can be supported by implementing mechanistic, computational methods. These methods can help to inform drug development by identifying key drug and formulation attributes, and their effects on drug release rates. This perspective, therefore, addresses current guidelines in place for oral IVIVC development, how they may differ for subcutaneously administered compounds, and how modeling and simulation can be implemented to inform design of these products. As such, integration of modeling and simulation with current IVIVC systems can help in driving the development of subcutaneous injectables.
Identifiants
pubmed: 37523013
doi: 10.1007/s11095-023-03572-3
pii: 10.1007/s11095-023-03572-3
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1633-1639Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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