Bioequivalence and Bioavailability Forum

Which version of Kinetica? [Study Performance]

posted by Helmut – Vienna, Austria, 2014-06-11 21:51 (3605 d 01:03 ago) – Posting: # 13059
Views: 16,683

Dear Khaoula,

I re-calculated your C_max-data in Kinetica v5.0.10. I didn’t import the “all missing” row of subject #15 and asked for log-transformed analysis. Now I’m even more confused. Below my results:


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

            LATIN SQUARE DESIGN : ANOVA TABLE for Cmax

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

LATIN SQUARE with Log (neperian) option





SOURCE       D.F    SS         MS          F         p

Period         1  0.0092314  0.0092314   0.174967  0.6826    NS

Subject(Seq)  13  5.18151    0.398578    7.55441   0.0004324 ***

Formulation    1  0.277381   0.277381    5.25731   0.03917   ***

Sequence       1  0.788575   0.788575   14.9462    0.001947  ***

Error         13  0.685892   0.0527609

Total         29  6.94259

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

                     N   Mean     SD         SEM     GeoMean  Geo SD

Formulation:num = R 15  6.13386  0.498125  0.128615  461.211  1.64563

Formulation:num = T 15  6.32617  0.477449  0.123277  559.01   1.61196

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

Root Mean Square Error = 0.229697 ; CV = 0.0368695



phi = 1.62131

Power of the test = 0.564385

1 - ( Power of the test ) = 0.435615

Minimum detectable difference = 0.192312

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

BIOEQUIVALENCE TESTS FOR

Level R and level T



Reference Confidence Interval: [0.8, 1.25]


Geomean Ratio (Test/Reference) = 1.21205

90% standard confidence interval

(around the ratio:[test form]/[ref form])=[1.0448, 1.4061]


t(0.05 - 13df) = 1.7709



  Cannot conclude equivalence.

Still wrong in many places, but closer to Phoenix/WinNonlin and R.

                 PE        90% CI       MSE     CV

PHX/WNL and R  121.02  104.22–140.53  0.053184 23.37

Kinetica 5     121.20  104.48–140.61  0.052761 23.28 (manually from MSE)

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Helmut Schütz

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Complete thread:

randomization khaoula 2014-06-06 14:04
- Imbalanced cross-overs Helmut 2014-06-06 14:47
  - Imbalanced cross-overs khaoula 2014-06-06 16:03
    - CV 0.03%? Helmut 2014-06-07 13:52
    - Imbalanced cross-overs jag009 2014-06-09 15:36
      - Imbalanced cross-overs khaoula 2014-06-09 22:07
        
        Bag full of bugs Helmut 2014-06-10 00:37
        
        Randomisation? ElMaestro 2014-06-10 01:00
        
        Randomisation? Helmut 2014-06-10 14:53
        
        Randomisation? khaoula 2014-06-11 00:17
        
        Problems resolved? Helmut 2014-06-11 02:01
        
        Problems resolved? khaoula 2014-07-24 13:36
        
        corrected data in PHX/WNL Helmut 2014-07-27 01:37
        
        Which version of Kinetica?Helmut 2014-06-11 19:51
        
        Which version of Kinetica? khaoula 2014-06-12 00:41
        Which version of Kinetica? khaoula 2014-07-25 00:49
        
        adjusted means (aka LSMs) Helmut 2014-07-27 02:23
        
        adjusted means (aka LSMs) khaoula 2014-08-25 21:41

Which version of Kinetica? [Study Per­for­mance]

Complete thread:

Which version of Kinetica? [Study Performance]