Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor.
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
17
11
2017
revised:
26
01
2018
accepted:
12
02
2018
pubmed:
16
2
2018
medline:
14
11
2019
entrez:
16
2
2018
Statut:
ppublish
Résumé
Model-informed drug development (MIDD) was central to the development of the oral proteasome inhibitor ixazomib, facilitating internal decisions (switch from body surface area (BSA)-based to fixed dosing, inclusive phase III trials, portfolio prioritization of ixazomib-based combinations, phase III dose for maintenance treatment), regulatory review (model-informed QT analysis, benefit-risk of 4 mg dose), and product labeling (absolute bioavailability and intrinsic/extrinsic factors). This review discusses the impact of MIDD in enabling patient-centric therapeutic optimization during the development of ixazomib.
Identifiants
pubmed: 29446068
doi: 10.1002/cpt.1047
pmc: PMC6585617
doi:
Substances chimiques
Boron Compounds
0
Proteasome Inhibitors
0
ixazomib
71050168A2
Glycine
TE7660XO1C
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
376-387Informations de copyright
© 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.
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