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Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor.

ABSTRACT: 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.

SUBMITTER: Gupta N 

PROVIDER: S-EPMC6585617 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor.

Gupta Neeraj N   Hanley Michael J MJ   Diderichsen Paul M PM   Yang Huyuan H   Ke Alice A   Teng Zhaoyang Z   Labotka Richard R   Berg Deborah D   Patel Chirag C   Liu Guohui G   van de Velde Helgi H   Venkatakrishnan Karthik K  

Clinical pharmacology and therapeutics 20180323 2

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  ...[more]

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