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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Detalles Bibliográficos
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
Descripción
Sumario: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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