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Forced degradation studies under all four ICH-specified stress conditions (heat, light, acid/base hydrolysis, oxidation) define the degradation pathways and confirm method specificity

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Novo Nordisk is currently evaluating the CRLs contents and plans to collaborate closely with the FDA to meet these requests

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108, 109 Thereby, insulin levels are only slightly decreased, but drop significantly together with blood glucose levels and body weight once calorie intake is also restricted