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The FDA's 2015 and subsequent guidance documents have questioned whether AOD-9604 qualifies as a bulk substance under 503A compounding rules, because it is not a component of an FDA-approved drug with the same active ingredient
The most practical approach for many protocols involves starting with a 5mg vial for the early escalation phases and switching to a 10mg vial once weekly doses are higher
Presented for research literature review only Sagara J et al
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