Bioequivalence and Bioavailability Forum

Hi,

❝ Our test product is a nutraceutical product, which can be marketed without any approval from regulatory, as per DSHEA. So our test product is already present in market, and we have to prove that it has superior bio availability as compared to the reference product. We can use the positive results of this study as a marketing tool for our product.

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❝ Our test product is a ODT and reference is a conventional formulation.

Questions:
Define Superiority. You mean for example your test/Ref Ratio in AUC would yield > 100%? If so 1) you might have to make justification that your dose is safe and tolerable if 5 mg is the max dose (not strength) of the RLD. If not then you have to dose adjust your product to give similar bio to the reference, like your product is 4 mg ODT and give equivalent peak and systemic exposure relative to RLD 5mg.

I think you can dose the reference as 5x1mg if the 5mg does not exist (but 5 mg dose must be within the max recommended dose). Note that this will not be an ANDA (generic filing). You are presenting a different platform and use a non-RLD.

I could be wrong since I don't deal with any agency outside FDA and TPD (and I don't deal with nutra stuff). I have done ODTs but we always claimed equivalency to a reference (and the filings were not ANDAs).

John