Ontology highlight
ABSTRACT:
SUBMITTER: Gupta N
PROVIDER: S-EPMC6585617 | biostudies-literature | 2019 Feb
REPOSITORIES: biostudies-literature
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]