## Sample size for the FDA NTID BE decision [Outliers]

Dear pjs,

❝ ... 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