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Registersubject inclusion question in replicate design for ANVISA [RSABE / ABEL]
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.
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» IMHO, this doesn’t make sense. See the example in the vignette of
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...
» » […] 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...
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All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- subject inclusion question in replicate design for ANVISA Shuanghe 2019-09-04 14:48 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- subject inclusion question in replicate design for ANVISA Helmut 2019-09-04 20:23
- subject inclusion question in replicate design for ANVISAShuanghe 2019-09-05 14:38
- subject inclusion question in replicate design for ANVISA Helmut 2019-09-04 20:23
Ing. Helmut Schütz