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

posted by jag009  – NJ, 2018-03-28 21:25 (1397 d 08:07 ago) – Posting: # 18606
Views: 8,891


» My motivation for the original question: it is conceivable that a one could find T(100mg) and R(112mg) BE with a large enough sample. It is also conceivable that one may find 125mg BE with 112mg. This would cause substantial risk of harm. I thought that perhaps imposing the CI through GMR of 1 limit may prevent this from happening.

I think your clarification above is even more confusing. Your example "T(100mg) vs R(112mg) is bioequivalent with a large enough sample size". Are you trying to say that a large enough sample size can force a 100 mg product and a 112 mg product to become bioequivalent because the BE window has a ± 20% around 100%? Please don't forget that there is a criteria on T/R total assay/potency to be within 5%. Your 110mg and 112 mg has >5% potency and that alone invalidates your example.


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