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RegisterSample size for Pivotal Partial Replicate desing [Power / Sample Size]
Dear All,
We have pilot data for partial reference replicate design (2 treatment, 3 period reference replicate design).
Based on pilot results for N=9 subjects, intra-subject cv of Cmax and AUC for reference product is 28% and 25%, respectively. The ratio (T/R) for Cmax and AUC is 115% and 114%, respectively. The power of the study for Cmax and AUC is below 70%.
It will be helpful if someone suggest me for the sample size calculation for pivotal partial replicated design (2 treatment, 3 period reference replicate design) using the above information?
Thanks and regards,
Nirav Jani
We have pilot data for partial reference replicate design (2 treatment, 3 period reference replicate design).
Based on pilot results for N=9 subjects, intra-subject cv of Cmax and AUC for reference product is 28% and 25%, respectively. The ratio (T/R) for Cmax and AUC is 115% and 114%, respectively. The power of the study for Cmax and AUC is below 70%.
It will be helpful if someone suggest me for the sample size calculation for pivotal partial replicated design (2 treatment, 3 period reference replicate design) using the above information?
Thanks and regards,
Nirav Jani
Complete thread:
- Sample size for Pivotal Partial Replicate desingNirav Jani 2011-02-03 19:32
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Sample size for Pivotal Partial Replicate desing ElMaestro 2011-02-03 20:41
- Sample size for scaled ABE? d_labes 2011-02-04 12:00
- Sample size for scaled ABE? ElMaestro 2011-02-04 13:23
- Remember "Do not's" d_labes 2011-02-04 14:00
- Remember "Do not's" Nirav Jani 2011-02-04 19:15
- Remember "Do not's" d_labes 2011-02-04 14:00
- Sample size for scaled ABE? ElMaestro 2011-02-04 13:23
- Sample size for scaled ABE? d_labes 2011-02-04 12:00
- Sample size for Pivotal Partial Replicate desing ElMaestro 2011-02-03 20:41
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