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Analytical guidance from ICH and FDA describes validation concepts for procedures used to evaluate identity, purity, assay, and related measurements [19] [20]

76 For instance, AARS1 functions as an intracellular lactate sensor, directly binding lactate to form lactate-AMP, and mediates lactylation of K120/139 on p53 within its DNA-binding domain (DBD), which prevents the binding of p53 to DNA containing p53 response elements (p53RE-DNA) and subsequent p53 liquidliquid phase separation (LLPS)

The injectable route makes more sense for wound healing and skin remodeling protocols where systemic distribution is the goal

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