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A 2year carcinogenicity study was conducted with exenatide extended-release, the active component of BYDUREON BCISE, in male and female rats at doses of 0.3, 1.0, and 3.0 mg/kg (2-, 10-, and 27-times human systemic exposure at the maximum recommended human dose (MRHD) of 2 mg/week

When a protein or peptide POI is fused to the Fc, the fusion proteins are called peptibodies, as opposed to antibodies, as depicted in Figure 3 and described later [89,90]

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How reactive metabolites induce an immune response that sometimes leads to an idiosyncratic drug reaction

A clear blue solution is expected