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For FDA bioequivalence analysis, as the estimated within-participant standard deviation for oral semaglutide, s(WR), was 0.294 for both co-primary endpoints, the reference-scaled average bioequivalence (RSABE) analysis was the primary analysis for AUC 024h,SS and C max, 024h,SS [34]
In this analysis, the increased risk was aligned with concerns discussed in earlier cohort studies
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Brand-name products like Ozempic and Wegovy come prefilled in injection pens because they use specialized preservative systems and undergo extensive stability testing at the manufacturing level
Only the two highest standard doses, 12.5mg and 15mg, exceed a single syringe capacity