Despite L-carnosine having demonstrated antioxidant properties (Boldyrev et al., 2013), it has no solid evidence of its clinical efficacy across the included trials
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However, in severe hepatic impairment or cirrhosis, the BNF and SmPC advise caution: the dose interval should be increased to at least every 6 hours, and the maximum daily dose may need to be reduced
When FDA investigators informed the firm that process validation had not been conducted prior to product distribution (which is a foundational cGMP requirement under 21 CFR 211.100), the company responded that it had been unaware of the legal obligation because its AI agent had never flagged it as a requirement
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