Sample size for the FDA NTID BE decision [Outliers]

posted by d_labes  – Berlin, Germany, 2017-10-05 19:25 (2366 d 06:46 ago) – Posting: # 17864
Views: 16,172

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

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
83 visitors (0 registered, 83 guests [including 11 identified bots]).
Forum time: 01:12 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5