Bioequivalence and Bioavailability Forum • Sample size for the FDA NTID BE decision

Sample size for the FDA NTID BE decision [Outliers]

posted by d_labes – Berlin, Germany, 2017-10-05 19:25 (1996 d 04:20 ago) – Posting: # 17864
Views: 15,551

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:

Outliers in Replicated Crossover Study pash413 2016-07-11 09:04
- Which agency? Helmut 2016-07-11 12:56
  - Which agency? pash413 2016-07-11 17:01
    - Residuals and Critical value Calculation? pash413 2016-07-14 08:00
- Outliers in Replicated Crossover Study DavidManteigas 2016-07-12 16:55
  - Outliers in Replicated Crossover Study Ohlbe 2016-07-12 17:50
- 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