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FDA Briefing Document, Pharmacy Compounding Advisory Committee (PCAC) Meeting, 29 October 2024
Evidence and Research Comparison# IGF-1 LR3 Research# IGF-1 LR3 has become the standard form of IGF-1 used in laboratory research and biomanufacturing: Cell culture : Widely used as a growth factor supplement in serum-free and low-serum culture media, where it provides significantly greater potency per unit mass compared to native IGF-1 Bioprocessing : Applied in manufacturing of biopharmaceuticals and cell-based therapies to support cell growth and viability In vitro pharmacology : Extensive characterization of receptor binding kinetics, downstream signaling, and effects on various cell types including myoblasts, osteoblasts, and neural progenitors Animal studies : Some preclinical data on systemic and local administration effects on muscle growth and recovery in rodent models No human clinical trials have been conducted with IGF-1 LR3
Brain activity mapping in Mecp2 mutant mice reveals functional deficits in forebrain circuits, including key nodes in the default mode network, that are reversed with ketamine treatment
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