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

posted by bebac_fan – US, 2018-03-28 23:57 (1305 d 05:19 ago) – Posting: # 18611
Views: 8,773

Hi ElMaestro,

» 2. I am not aware of any problem of any kind, which has practical relevance and which can be solved by imposing a mandatory span for the CI across the 100% mark.

This is what I was looking for. Thank you for lending your knowledge!

The problem I describe may already exist for e.g. levothyroxine, with a Swr around 0.2, and many narrowly separated strengths (e.g. 100, 112, 125 mcg).

Using FDA NTID guidelines, I think it would be plausible to pass a formulation with GMR of 1.03-1.09 and another with a GMR of 0.93 - 0.99. In that case, a 100mcg tablet w/ GMR of 1.03-1.09 and 112mcg tablet w/ GMR of 0.93-0.99 would be biologically indistinguishable, which is concerning.

So we figured out that my proposed solution is not a good idea. How would you go about solving it?


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