Bioequivalence and Bioavailability Forum • Sample size calculation

Sample size calculation [RSABE / ABEL]

posted by BE-proff – 2016-12-14 09:56 (3127 d 12:02 ago) – Posting: # 16843
Views: 7,070

Hi All,

Let's say I want to calculate sample size for a BE-study using the following data:

CVintra of Cmax= 39.8%
Power= at least 80%
GMR = 1.15

I want to utilize 2x2x4 design with reference scaling and PowerTOST gives me:

library(PowerTOST)

sampleN.scABEL.ad(CV=0.398, theta0=1.15, targetpower=0.80, design="2x2x4")



+++++++++++ scaled (widened) ABEL +++++++++++

            Sample size estimation

        for iteratively adjusted alpha

---------------------------------------------

Study design: 2x2x4 (RTRT|TRTR)

log-transformed data (multiplicative model)

1,000,000 studies in each iteration simulated.



Expected CVwR 0.398

Nominal alpha      : 0.05 

True ratio         : 1.1500 

Target power       : 0.8 

Regulatory settings: EMA (ABEL)

Switching CVwR     : 0.3 

 Regulatory constant: 0.76 

Expanded limits    : 0.7472...1.3383

Upper scaling cap  : CVwR > 0.5 

PE constraints     : 0.8000 ... 1.2500

n  48,   adj. alpha: 0.04444 (power 0.8100), TIE: 0.05000

Is it correct that:

- at least 48 subjects to be randomized
- CI for Cmax is 0.74 - 1.34
- CIs for AUCs are 0.80-1.25

Complete thread:

Sample size calculationBE-proff 2016-12-14 08:56 [RSABE / ABEL]
- Sample size estimation for iteratively adjusted α Helmut 2016-12-14 16:24
  - Sample size estimation for iteratively adjusted α BE-proff 2016-12-14 19:43
  - Sample size estimation for iteratively adjusted α BE-proff 2016-12-20 21:47
    - (1-2*alpha) CI d_labes 2016-12-21 11:15
      - Script kiddy Helmut 2016-12-21 18:09