Sample size for the FDA NTID BE decision [Outliers]
Dear pjs,
Not exactly what you have requested, but the whole BE decision. Namely: For deciding BE the study must pass the 95% upper CI of the linearized RSABE criterion <0, the conventional ABE test and additionally the test that the ratio of sWT/sWR is <= 2.5.
R package
Have a look if this fits your needs.
❝ ... is there any program to calculate the sample size for which upper limit of the 90% equal-tails confidence interval for σWT/σWR can be lesser than 2.5.
Not exactly what you have requested, but the whole BE decision. Namely: For deciding BE the study must pass the 95% upper CI of the linearized RSABE criterion <0, the conventional ABE test and additionally the test that the ratio of sWT/sWR is <= 2.5.
R package
PowerTOST
has the functions power.NTIDFDA()
/ sampleN.NTIDFDA()
Have a look if this fits your needs.
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
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- Outliers in Replicated Crossover Study DavidManteigas 2016-07-12 16:55
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- Outliers in Replicated Crossover Study ElMaestro 2016-07-13 18:49
- I would stop Helmut 2016-07-13 19:56
- Outliers in Replicated Crossover Study pjs 2017-10-05 15:46
- Sample size for the FDA NTID BE decisiond_labes 2017-10-05 17:25
- Which agency? Helmut 2016-07-11 12:56