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Regulatory bodies like the USP and FDA set stringent quality controls and labeling requirements for BWFI, even for RUO products

They do not, on their own, demonstrate clinical benefit in people that is the job of the human trials discussed later in this article

most people recover fully with dedicated conservative care

Next steps in clinical translation First-in-human safety trials (phase I) are essential: to assess dose tolerability, pharmacokinetics, biodistribution, peptide half-life, clearance, immunogenicity

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However, such approaches were known to eventually deteriorate into a clumpy, unhealthy form