Dosing Schedules from Published Research Phase 2 Trial Dose Groups The Phase 2 clinical trial published in NEJM employed the following dose groups, all administered via subcutaneous injection once weekly: Scroll sideways to view the full table on mobile
So they can only compound peptides that fall into five strict categories: FDA-approved peptides for human use (e.g., sermorelin) FDA GRAS (Generally Recognized as Safe) peptides (historical regulatory status) Peptides with a USP monograph (United States Pharmacopeia standard) Peptides on the FDA 503A Bulks List (official pre-approved list for compounders) Peptides in Category I of the interim 503A Bulks List (temporary pathway, under review) Nearly all peptides marketed for wellness, recovery, or longevity (as noted in regulatory guidance from Frier Levitt legal authority on peptide compounding and the American Medical Association on injectable peptides) do not fall into these five categories
Therefore, you should always check the agencys website or call the committees Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting
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It helps to picture the chemistry
Donnenfeld is a consultant for Omeros
