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Although ICH Q2(R2) is primarily intended for pharmaceutical analytical procedures, its fit-for-purpose validation principles may be used as a non-mandatory scientific reference for research-reagent testing

In addition, commercially available products may present other limitations : Fixed dosing that does not allow for gradual titration Lack of preservative-free or dye-free options Absence of certain medications in oral form in the United States Limited flexibility in combining therapies to match multisystem symptom patterns In many MCAS cases, therapies cannot be fully implemented using commercially manufactured products alone

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However, the lack of clinical trials means that there could potentially be serious BPC-157 side effects in humans, which remain unknown

It is a compound that works best when levels are maintained consistently over time

The goal isn't to zero out oxidative stress