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

posted by Shuanghe  – Spain, 2015-01-08 11:08 (2523 d 13:12 ago) – Posting: # 14252
Views: 27,347

Hi all,

If I can generalise the question in original post to "Subjects to be considered in replicate BE study in EU/FDA submission" to avoid a new post.

For 3-period partial replicate BE I did the same thing as mentioned by Detlew.
To state it briefly:The last 2 is "done automatically" as Detlew said but I would prefer to state it very clearly in the protocol just in case. ;-)

For 4-period full replicate BE for FDA submission, what I did is the following and I'd appreciate any comments:For the first point, it seems there's no point to included subject without any data of R. What's your thought?

The 2nd and 3rd points are answers from FDA.

In one of the original questions I suggested to modify their code to included subjects with 1T2R, 2T1R etc but they stress that only subjects with 4 periods should be included for BE but all subject with 2R, even without any T, should be used for Swr. So the code is too sacred to be changed. :-D

The last point is a recent addition (as I forgot to ask FDA years ago) from one replicate study that happened to have high dropout rate (missing 1 or 2 periods) but ISCV of one PK parameter is less than the HVDP criterion so no scaled approach for that parameter. But the protocol didn't have the point 4 so only subjects with 4 periods were included and the power is sh** due to few subjects we have!
so any suggestions on this point?

For EU it seems much easier as the sample data set in the PK Q/A document has some missing periods (but all have at least 1T and 1R).

All the best,
Shuanghe

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