Bioequivalence and Bioavailability Forum • TIE for NTIDs

TIE for NTIDs [Power / Sample Size]

posted by Astea – Russia, 2018-02-04 21:04 (2542 d 19:46 ago) – Posting: # 18342
Views: 21,196

Dear Helmut! Thank you for the rectification! Till you and Detlew care about it, the world can breathe calmly!

Dear Detlew!

And what about the different CI for two metrics? Can you invent smthg like Power2.RSABE or Power2.NTIDFDA or it is a stupid idea?

My thoughts are as follows: according to some product specific EMA guideline (sirolimus for example) we should shorten the limit only for AUC but not for Cmax. May it leed to TIE inflation or not?

For an extreme example, suppose we calculate sample size, basing on CV 25% (I understand that NTID should not have large variance but nevertherless): sampleN.TOST(CV=0.25, theta0=0.975, theta1=0.9, theta2=1.11, design="2x2")
122 volunteers!

Then by using Power.2TOST for CV=0.3 I get TIE very slightly upper than 0.05

 power.2TOST(CV=c(0.3,0.25), n=122, theta1=c(0.8, 0.9), theta2=c(1.25, 1.11), theta0=c(1, 1.11), rho=0)

[1] 0.05000002

In this case the diference from 0.05 is negligible, but may be one could find more rude example? Or am I using or interpretate power.2TOST uncorrectly?

❝ Try this (for the homoscedastic case swR=swT):

And what to do if variances are different (non-negotiable word heteroscedasticity)?

—
"Being in minority, even a minority of one, did not make you mad"

Complete thread:

Sample size for 4-period 4-sequence crossover BE study Bryony Simmons 2018-02-01 12:16 [Power / Sample Size]
- function sampleN.TOST of package PowerTOST Helmut 2018-02-01 13:01
  - Alpha adjustment in higher order crossover d_labes 2018-02-01 14:01
    - Deficiencies Helmut 2018-02-01 15:48
      - Deficiencies nobody 2018-02-01 17:10
      - Deficiencies d_labes 2018-02-01 18:57
        
        Deficiencies Relaxation 2018-02-02 11:12
        
        Deficiencies nobody 2018-02-02 12:49
        Deficiencies Helmut 2018-02-02 16:14
        
        Deficiencies Relaxation 2018-02-02 19:41
        
        alpha... where is omega? Astea 2018-02-02 21:45
        
        α and no ω Helmut 2018-02-02 23:39
        
        TIE for NTIDs d_labes 2018-02-04 12:40
        
        TIE for NTIDsAstea 2018-02-04 20:04
        
        TIE for NTIDs Helmut 2018-02-05 01:01
        
        TIE for NTIDs d_labes 2018-02-05 16:40
        
        TIE for NTIDs Helmut 2018-02-05 17:49
        
        TIE for NTIDs d_labes 2018-02-05 22:17
        
        TIE for NTIDs Helmut 2018-02-06 12:34
        
        TIE for NTIDs d_labes 2018-02-05 16:35
        
        bow TIE for NTIDs Astea 2018-02-05 17:52
        
        bow TIE for NTIDs Helmut 2018-02-05 18:10
        
        111.11 for NTIDs Astea 2018-02-05 19:27
        
        111.11 for NTIDs Helmut 2018-02-06 00:12
        
        bow TIE for NTIDs d_labes 2018-02-05 22:33