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Characterized by insulin resistance, gradual progressive loss of insulin secretion by -cells, and being heavily driven by being overweight or obese [98], T2DM leads to hyperglycemia, excessive urine production, increased risk of cardiovascular disease, and changes in energy metabolism [106]

While US and EU requirements are largely harmonized, some tests are jurisdiction-specific for example, Shot Weight testing is an FDA-only requirement, while the EMA focuses on Delivered Dose Uniformity through container life