Dropouts and Missing Values in RSABE [RSABE / ABEL]

posted by d_labes  – Berlin, Germany, 2016-05-04 11:27 (3296 d 15:33 ago) – Posting: # 16280
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Dear munsoned,

❝ My question has two parts.


Where is part two?

Answer to part one:
If you study the SAS code given in the FDA progesterone guidance for the evaluation of the 2x2x4 full replicate design you will discover that for the analysis of T versus R subjects must have all four periods to be included.
For the analysis of the intra-subject variability of the Reference subjects must have results for both periods in which the reference was applied.
For the "nice to have" analysis of the intra-subject variability of Test the analogous applies.

Thus it may happen that the different analyses may have different degrees of freedom. If this is reasonable is up to you.

See also this thread and this also.

Regards,

Detlew

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