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In its briefing materials, FDA staff concluded the evidence weighed against adding these peptides, citing limited proof of effectiveness, gaps in how the substances are chemically characterized, and unresolved questions about impurities and immune reactions
Demonstrating some passage in an animal model does not establish predictable human brain exposure from a commercial formulation
[1] Some compounders suggest adding B12 to tirzepatide formulations based on theoretical concerns about vitamin B12 absorption, though it's important to note that clinical evidence specifically linking tirzepatide to B12 deficiency is lacking
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