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Accumulated SAICA riboside is thought to be the primary neurotoxicant involved in this disorder, based on animal models (79)
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Under 21 CFR 216.23(c), FDA weighs four criteria when considering a substance for the list: physical and chemical characterization, safety issues raised by use in compounded drug products, available evidence of effectiveness or lack of effectiveness, and historical use in compounded drug products including references in peer-reviewed medical literature [4]
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