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Feature · Product Review
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Description

According to the ICH E19 guidance finalized in December 2022, (Selective Safety Data Collection) SSDC may be applied in specific pre-approval or post-approval late-stage clinical trials where the safety profile of a drug is well established (ICH, 2022)

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The Satiety and Clinical Adiposity Liraglutide Evidence (SCALE) Obesity and Prediabetes randomized, double-blind, placebo-controlled trial of 3.0 mg of once daily liraglutide achieved a mean 8.4 kg weight loss in patients with obesity without T2DM [7]

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