Bioequivalence and Bioavailability Forum

corrected data in PHX/WNL [Study Performance]

posted by Helmut – Vienna, Austria, 2014-07-27 03:37 (3927 d 10:08 ago) – Posting: # 13317
Views: 18,369

Hi Khaoula!

❝ […] can you use the right results and recalculate it with your software kinetica v5 and Phoenix/WinNonlin?

Meanwhile I retired the machine where Kinetica is installed on. Results from Phoenix/WinNonlin 6.3:

Hypothesis       DF    SS        MS       F_stat  P_value

Period            1  0.206671  0.206671  0.55377  0.47002

Sequence*Patient 13  4.851704  0.373208  7.80516  0.00036

Sequence          1  0.087929  0.087929  1.83892  0.19816

Formulation       1  0.202662  0.202662  4.23841  0.06014

Error            13  0.621602  0.047816



RefLSM  6.1477 (RefGeoLSM  467.64)

TestLSM 6.3125 (TestGeoLSM 551.40)

Diff    0.1647 (SE 0.08002, df 13)



T/R 117.91% [90% CI: 102.33%, 135.86%]




Parameter              Estimate

Var(Sequence*Patient)  0.162696

Var(Residual)          0.047816

Intersubject CV        0.420332

Intrasubject CV        0.221308

Checks:
T/R = 100(551.40/467.64) = 100ℯ^0.1647 = 117.91%
90% CI = 100ℯ^{0.1647±1.7709√0.047816(1/(2×8)+1/(2×7))} = 102.33–135.86%
CV% = 100√ℯ^0.047816 – 1 = 21.13%

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Helmut Schütz

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Complete thread:

randomization khaoula 2014-06-06 14:04 [Study Performance]
- 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/WNLHelmut 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

corrected data in PHX/WNL [Study Per­for­mance]

Complete thread:

corrected data in PHX/WNL [Study Performance]