A Model-Informed Drug Discovery and Development Strategy for the Novel Glucose-Responsive Insulin MK-2640 Enabled Rapid Decision Making.
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ABSTRACT:
SUBMITTER: Visser SAG
PROVIDER: S-EPMC7325312 | biostudies-literature | 2020 Jun
REPOSITORIES: biostudies-literature
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A Model-Informed Drug Discovery and Development Strategy for the Novel Glucose-Responsive Insulin MK-2640 Enabled Rapid Decision Making.
Visser Sandra A G SAG Kandala Bhargava B Fancourt Craig C Krug Alexander W AW Cho Carolyn R CR
Clinical pharmacology and therapeutics 20200203 6
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 ...[more]
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