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Clinical bridging: The scientific rationale The core of any 505(b)(2) application is the Scientific Bridge. You cannot simply ask the FDA to skip studies
By binding to IGF-1R, IGF-1 can affect metabolism, cell growth (hypertrophy), differentiation and cell division (hyperplasia), prevention of cell death (apoptosis), normal development, and even malignant growth
These symptoms are typically most pronounced when starting treatment or immediately after increasing a dose
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