Model-Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
© 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:105 |
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| Enthalten in: |
Clinical pharmacology and therapeutics - 105(2019), 2 vom: 14. Feb., Seite 376-387 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gupta, Neeraj [VerfasserIn] |
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| Links: |
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| Themen: |
71050168A2 |
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| Anmerkungen: |
Date Completed 13.11.2019 Date Revised 06.03.2020 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/cpt.1047 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM281047367 |
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| 520 | |a 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 | ||
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| 700 | 1 | |a Yang, Huyuan |e verfasserin |4 aut | |
| 700 | 1 | |a Ke, Alice |e verfasserin |4 aut | |
| 700 | 1 | |a Teng, Zhaoyang |e verfasserin |4 aut | |
| 700 | 1 | |a Labotka, Richard |e verfasserin |4 aut | |
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| 700 | 1 | |a van de Velde, Helgi |e verfasserin |4 aut | |
| 700 | 1 | |a Venkatakrishnan, Karthik |e verfasserin |4 aut | |
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