A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making

A model‐informed drug discovery and development strategy played a key role in the novel glucose‐responsive insulin MK‐2640’s early clinical development strategy and supported a novel clinical trial paradigm to assess glucose responsiveness. The development and application of in silico modeling appro...

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Autores principales: Visser, Sandra A.G., Kandala, Bhargava, Fancourt, Craig, Krug, Alexander W., Cho, Carolyn R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Tutorial
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325312/
https://www.ncbi.nlm.nih.gov/pubmed/31889297
http://dx.doi.org/10.1002/cpt.1729
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author Visser, Sandra A.G.
Kandala, Bhargava
Fancourt, Craig
Krug, Alexander W.
Cho, Carolyn R.
author_facet Visser, Sandra A.G.
Kandala, Bhargava
Fancourt, Craig
Krug, Alexander W.
Cho, Carolyn R.
author_sort Visser, Sandra A.G.
collection PubMed
description A model‐informed drug discovery and development strategy played a key role in the novel glucose‐responsive insulin MK‐2640’s early clinical development strategy and supported a novel clinical trial paradigm to assess glucose responsiveness. The development and application of in silico modeling approaches by leveraging substantial published clinical insulin pharmacokinetic–pharmacodynamic (PKPD) data and emerging preclinical and clinical data enabled rapid quantitative decision making. Learnings can be applied to define PKPD properties of novel insulins that could become therapeutically meaningful for diabetic patients.
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spelling pubmed-73253122020-07-01 A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making Visser, Sandra A.G. Kandala, Bhargava Fancourt, Craig Krug, Alexander W. Cho, Carolyn R. Clin Pharmacol Ther Tutorial A model‐informed drug discovery and development strategy played a key role in the novel glucose‐responsive insulin MK‐2640’s early clinical development strategy and supported a novel clinical trial paradigm to assess glucose responsiveness. The development and application of in silico modeling approaches by leveraging substantial published clinical insulin pharmacokinetic–pharmacodynamic (PKPD) data and emerging preclinical and clinical data enabled rapid quantitative decision making. Learnings can be applied to define PKPD properties of novel insulins that could become therapeutically meaningful for diabetic patients. John Wiley and Sons Inc. 2020-02-03 2020-06 /pmc/articles/PMC7325312/ /pubmed/31889297 http://dx.doi.org/10.1002/cpt.1729 Text en © 2019 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/3.0/ 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 Tutorial
Visser, Sandra A.G.
Kandala, Bhargava
Fancourt, Craig
Krug, Alexander W.
Cho, Carolyn R.
A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making
title A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making
title_full A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making
title_fullStr A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making
title_full_unstemmed A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making
title_short A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making
title_sort model‐informed drug discovery and development strategy for the novel glucose‐responsive insulin mk‐2640 enabled rapid decision making
topic Tutorial
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7325312/
https://www.ncbi.nlm.nih.gov/pubmed/31889297
http://dx.doi.org/10.1002/cpt.1729
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