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

posted by Shuanghe  – Spain, 2019-09-05 16:38 (1665 d 22:02 ago) – Posting: # 20544
Views: 2,400

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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