Partial-replicated crossover study with 2 Tests [RSABE / ABEL]
Dear ElMaestro, dear MGR!
Both of your described designs are of course possible ones.
But both are not usable if you think in terms of scaled ABE for NTID's as described in the Warfarine guidance. The algo described there relies on a full replicate design because you have to evaluate the (1 - α)100% CI for σwT/σwR, the ratio of sd's of intra-subject variabilities of Test and Reference.
For "normal" scaled ABE aimed to a FDA submission there are some (IMHO) unresolved issues. Just to name some:
Both of your described designs are of course possible ones.
But both are not usable if you think in terms of scaled ABE for NTID's as described in the Warfarine guidance. The algo described there relies on a full replicate design because you have to evaluate the (1 - α)100% CI for σwT/σwR, the ratio of sd's of intra-subject variabilities of Test and Reference.
For "normal" scaled ABE aimed to a FDA submission there are some (IMHO) unresolved issues. Just to name some:
- How to estimate the sample size for scaled ABE for these designs?
- How exactly to adapt the algorithm described in the FDA Progesterone guidance to both suggested designs?
- Pairwise evaluation like the EMA suggestion for 3×3 or 4×4 cross-over designs doesn't really help since for the RR evaluation all data have to be used if such designs should have any advantage over 2 separate studies.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- SAS code for 3-period, partial-replicated crossover study scorp2011 2015-06-15 12:36 [RSABE / ABEL]
- SAS code for 3-period, partial-replicated crossover study d_labes 2015-06-15 13:24
- SAS code for 3-period, partial-replicated crossover study MGR 2015-06-15 13:34
- SAS code for 3-period, partial-replicated crossover study ElMaestro 2015-06-15 13:46
- Partial-replicated crossover study with 2 Testsd_labes 2015-06-15 14:50
- SAS code for 3-period, partial-replicated crossover study ElMaestro 2015-06-15 13:46
- SAS code for 3-period, partial-replicated crossover study MGR 2015-06-15 13:34
- SAS code for 3-period, partial-replicated crossover study d_labes 2015-06-15 13:24