[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by ElMaestro  – Denmark, 2018-03-28 21:44 (2013 d 22:16 ago) – Posting: # 18604
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Dear bebac_fan,

❝ I understand this is also a potential mechanism of abuse to get poor drugs approved: Sponsors may increase sample sizes arbitrarily to meet BE. Would my proposed approach prevent that?

This is the wrong thinking, in my opinion. If the CI is within the limits then the product is BE, full stop. If you have reason to think the product is BE, then you have reason to apply a sample size appropriate for demonstrating it. Bear in mind that absence of a result indicating bioequivalence does not necessarily imply that the products are bioinequivalent

❝ Lets take a drug that comes in 100, 112, and 125. Theoretically, a sponsor could get 100, 112, AND 125 dosage forms (assuming CMC doesn't catch it) approved for 112 if they use sample sizes big enough :) This is my biggest concern.

Can you re-word this? I cannot understand what you mean.

Pass or fail!

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