Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Gupta, Neeraj, Hanley, Michael J., Diderichsen, Paul M., Yang, Huyuan, Ke, Alice, Teng, Zhaoyang, Labotka, Richard, Berg, Deborah, Patel, Chirag, Liu, Guohui, van de Velde, Helgi, Venkatakrishnan, Karthik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2018
Materias:
Reviews
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585617/
https://www.ncbi.nlm.nih.gov/pubmed/29446068
http://dx.doi.org/10.1002/cpt.1047
_version_ 1783428734775197696
author Gupta, Neeraj
Hanley, Michael J.
Diderichsen, Paul M.
Yang, Huyuan
Ke, Alice
Teng, Zhaoyang
Labotka, Richard
Berg, Deborah
Patel, Chirag
Liu, Guohui
van de Velde, Helgi
Venkatakrishnan, Karthik
author_facet Gupta, Neeraj
Hanley, Michael J.
Diderichsen, Paul M.
Yang, Huyuan
Ke, Alice
Teng, Zhaoyang
Labotka, Richard
Berg, Deborah
Patel, Chirag
Liu, Guohui
van de Velde, Helgi
Venkatakrishnan, Karthik
author_sort Gupta, Neeraj
collection PubMed
description 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.
format Online
Article
Text
id pubmed-6585617
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher John Wiley and Sons Inc.
record_format MEDLINE/PubMed
spelling pubmed-65856172019-06-27 Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor Gupta, Neeraj Hanley, Michael J. Diderichsen, Paul M. Yang, Huyuan Ke, Alice Teng, Zhaoyang Labotka, Richard Berg, Deborah Patel, Chirag Liu, Guohui van de Velde, Helgi Venkatakrishnan, Karthik Clin Pharmacol Ther Reviews 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. John Wiley and Sons Inc. 2018-03-23 2019-02 /pmc/articles/PMC6585617/ /pubmed/29446068 http://dx.doi.org/10.1002/cpt.1047 Text en © 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Reviews
Gupta, Neeraj
Hanley, Michael J.
Diderichsen, Paul M.
Yang, Huyuan
Ke, Alice
Teng, Zhaoyang
Labotka, Richard
Berg, Deborah
Patel, Chirag
Liu, Guohui
van de Velde, Helgi
Venkatakrishnan, Karthik
Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
title Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
title_full Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
title_fullStr Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
title_full_unstemmed Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
title_short Model‐Informed Drug Development for Ixazomib, an Oral Proteasome Inhibitor
title_sort model‐informed drug development for ixazomib, an oral proteasome inhibitor
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6585617/
https://www.ncbi.nlm.nih.gov/pubmed/29446068
http://dx.doi.org/10.1002/cpt.1047
work_keys_str_mv AT guptaneeraj modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT hanleymichaelj modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT diderichsenpaulm modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT yanghuyuan modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT kealice modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT tengzhaoyang modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT labotkarichard modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT bergdeborah modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT patelchirag modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT liuguohui modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT vandeveldehelgi modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor
AT venkatakrishnankarthik modelinformeddrugdevelopmentforixazomibanoralproteasomeinhibitor

Ejemplares similares