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

posted by bebac_fan – US, 2018-03-28 23:59 (2308 d 16:50 ago) – Posting: # 18609
Views: 10,590

Hi John,

Thanks for your response. Let me see if I can clear this up.

❝ 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%?

Kind of. I am saying that a large enough sample size can force a test product with e.g. 89% relative BA (e.g. 100mg/112mg) relative to RLD to pass. The difference between 100 and 112mg is clinically significant for this product. I am wondering if adding the condition I talked about from the beginning would help.

I was using the 100/112/125 example rather than talking about relative F to try to elucidate the clinical scenario, which I am doing a poor job of.

❝ 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.

I haven't. Thanks!


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