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Diabetologia 2022
GLP-1RAs and dual GLP-1/GIP receptor agonists have demonstrated therapeutic potential in animal models and clinical settings
The firm in its response described a cleanroom remodel , but the FDA found the supporting documentation insufficient: no specification documentation for ceiling tiles, no demonstration that materials are suitable for pharmaceutical use, no updated cleanroom certification, and no environmental monitoring data for the remodeled suite
Tirzepatide, the newest dual GLP-1/GIP receptor agonist, has a similar 5-day half-life, but limited data suggest potentially less gastric emptying delay compared to pure GLP-1 agonists due to dual receptor activation [30]
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