Bioequivalence and Bioavailability Forum • subject inclusion question in replicate design for ANVISA

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

posted by Shuanghe – Spain, 2019-09-05 16:38 (2052 d 08:02 ago) – Posting: # 20544
Views: 3,458

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...

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All the best,
Shuanghe

Complete thread:

subject inclusion question in replicate design for ANVISA Shuanghe 2019-09-04 14:48 [RSABE / ABEL]
- 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