Subjects in replicate BE study EU/FDA [RSABE / ABEL]

posted by cher0424 – China, 2015-01-08 13:56 (2691 d 07:24 ago) – Posting: # 14254
Views: 27,138

(edited by cher0424 on 2015-01-08 14:25)

Hi Shuanghe,
First Thank you for spelling out.

» For 4-period full replicate BE for FDA submission, what I did is the following and I'd appreciate any comments:
» – for scaled approach, only subject who complete all 4 periods will be included for BE evaluation
» – if Swr is less than the criterion for scaled approach then average BE approach will be used and all subject who can provide at least 1T and 1R will be included for BE evaluation.

So 3-period partial replicate BE for scaled approach is the same as above?
And the second point need to be writen in the protocol? otherwise can't be applied?

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