Bioequivalence and Bioavailability Forum • sampleN.TOST and CI.BE

sampleN.TOST and CI.BE [Power / Sample Size]

posted by Rocco_M – Mexico, 2019-09-18 00:02 (2054 d 07:20 ago) – Posting: # 20608
Views: 8,093

Okay gracias. That was a brain fart on my end. I now see that it is equivalent to 1/n1 + 1/n2.

One last question. If I use sampleN.tost and input
sampleN.TOST(CV=.3, theta0=1.0, theta1= 0.8, theta2=1.25, logscale=TRUE, alpha=0.05, targetpower=0.9, design="parallel")

I get sample size minimum be 78 total.

But then if I run CI.BE(pe=1.0, CV=.3, design="parallel", n=24)
I get CI = approx [0.81, 1.23].

This confuse me. Shouldn’t I need to enter n at least 78 in order to get CI within [.8, 1.25]?

Maybe I confuse concepts. In other words, what are implications if study *meet* bioequivalence but is underpowered?

Complete thread:

Input for CV when small first-in-man has been run Rocco_M 2019-09-03 18:45 [Power / Sample Size]
- Geometric mean and CV Helmut 2019-09-05 14:05
  - Geometric mean and CV Rocco_M 2019-09-05 23:49
    - Geometric mean and CV Helmut 2019-09-06 00:15
      - Geometric mean and CV Rocco_M 2019-09-06 17:49
        
        Geometric mean and CV Helmut 2019-09-06 18:15
        
        Geometric mean and CV ElMaestro 2019-09-06 19:03
        
        Geometric mean and CV Helmut 2019-09-07 09:57
        
        Geometric mean and CV Rocco_M 2019-09-09 13:31
        
        Assumptions… Helmut 2019-09-09 14:09
        
        Assumptions… Rocco_M 2019-09-09 16:35
        
        Assumptions… Helmut 2019-09-09 17:19
        
        Assumptions… Rocco_M 2019-09-13 21:28
        
        t-test & Welch-test Helmut 2019-09-14 00:16
        
        sampleN.TOST and CI.BERocco_M 2019-09-17 22:02
        
        assumptions vs. realizations Helmut 2019-09-18 11:04