subject inclusion question in replicate design for ANVISA [RSABE / ABEL]

posted by Shuanghe  – Spain, 2019-09-05 14:38 (877 d 00:28 ago) – Posting: # 20544
Views: 1,822

Hi Helmut,

» » […] the client's statistical consultant commented that only subjects who complete all 4 period (2T+2R) should be included, otherwise, they should be excluded even if they completed 3 period.
»
» IMHO, this doesn’t make sense. See the example in the vignette of replicateBE.

Thanks. That's my thought too so I insisted that the statistical section should be kept unchanged. Hopefully ANVISA will issue their own guideline soon...

All the best,
Shuanghe

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