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For an alternative path through full FDA approval as a new drug, the requirements are an order of magnitude higher: a sponsor-led IND program, a phase 1 safety study, dose-finding in humans, phase 2 efficacy in a target indication, phase 3 confirmatory trials, NDA submission, and FDA review
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Peptide reconstitution solution, such as bacteriostatic water, is specifically formulated for dissolving freeze-dried peptides in research settings
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