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

posted by bebac_fan – US, 2018-03-28 19:23 (1305 d 10:21 ago) – Posting: # 18603
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Dear ElMaestro,

Thank you for your input. I agree that this rule would punish sponsors have high sample sizes.

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?

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.

Thanks again for your input -
bebac_fan


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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