Bioequivalence and Bioavailability Forum • PHX build 6.3.0.395 / 6.4.0.511

PHX build 6.3.0.395 / 6.4.0.511 [Software]

posted by Helmut – Vienna, Austria, 2014-02-02 03:04 (4097 d 18:25 ago) – Posting: # 12310
Views: 28,026

Hi Yung-jin,

❝ […] Could you present the results (part of it will be good enough) from running PHX (or its beta)?

There are small differences to bear, since I started from the raw data and performed NCA first. This is a complete, balanced data set; therefore, the same results for subject(sequence) random or fixed are expected.

Table Partial SS

Dependent  Hypothesis       DF        SS        MS F_stat P_value

Ln(Cmax)   Sequence          1 0.0006903 0.0006903 0.02920 0.8672

Ln(Cmax)   Sequence*Subject 12 0.2836764 0.0236397 1.32782 0.3155

Ln(Cmax)   Formulation       1 0.0181691 0.0181691 1.02054 0.3323

Ln(Cmax)   Period            1 0.0362379 0.0362379 2.03545 0.1792

Ln(Cmax)   Error            12 0.2136406 0.0178034

Ln(AUCt)   Sequence          1 0.0151077 0.0151077 0.71554 0.4142

Ln(AUCt)   Sequence*Subject 12 0.2533637 0.0211136 0.63428 0.7791

Ln(AUCt)   Formulation       1 0.0108554 0.0108554 0.32611 0.5785

Ln(AUCt)   Period            1 0.0368259 0.0368259 1.10629 0.3136

Ln(AUCt)   Error            12 0.3994534 0.0332878

Ln(AUCinf) Sequence          1 0.0143291 0.0143291 0.76043 0.4003

Ln(AUCinf) Sequence*Subject 12 0.2261202 0.0188434 0.60445 0.8022

Ln(AUCinf) Formulation       1 0.0150303 0.0150303 0.48214 0.5007

Ln(AUCinf) Period            1 0.0346915 0.0346915 1.11282 0.3122

Ln(AUCinf) Error            12 0.3740929 0.0311744

This table is missing for the fixed effects model in the current release 6.3 (build 6.3.0.395) – therefore my workaround, but available in pre-release 1.4 (build 6.4.0.511).

Of course in the mixed model for AUCt and AUCinf:

Warning 11094: Negative final variance component. Consider omitting this VC structure.

Table Final Variance parameters (mixed)

Dependent  Parameter              Estimate

Ln(Cmax)   Var(Sequence*Subject)  0.0029182

Ln(Cmax)   Var(Residual)          0.0178034

Ln(Cmax)   Intersubject CV        0.0540594

Ln(Cmax)   Intrasubject CV        0.1340254

Ln(AUCt)   Var(Sequence*Subject) -0.0060871

Ln(AUCt)   Var(Residual)          0.0332878

Ln(AUCt)   Intrasubject CV        0.1839783

Ln(AUCinf) Var(Sequence*Subject) -0.0061655

Ln(AUCinf) Var(Residual)          0.0311744

Ln(AUCinf) Intrasubject CV        0.1779478

Table Final Variance parameters (fixed)

Dependent  Parameter              Estimate

Ln(Cmax)   Var(Residual)          0.0178034

Ln(AUCt)   Var(Residual)          0.0332878

Ln(AUCinf) Var(Residual)          0.0311744

Note the CV_intra is not reported (why not?)…

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Complete thread:

How to calculate intersubject variability in PHX WinNonlin zan 2014-01-29 23:58
- Negative variance component Helmut 2014-01-30 01:16
  - Negative variance component zan 2014-01-30 18:11
  - Negative variance component zan 2014-01-31 00:16
    - Negative variance component ElMaestro 2014-01-31 08:20
    - Negative variance component yjlee168 2014-01-31 10:26
      - Example data set Helmut 2014-02-01 16:03
        
        Example data set yjlee168 2014-02-01 17:40
        
        PHX build 6.3.0.395 / 6.4.0.511Helmut 2014-02-02 02:04
        
        PHX build 6.3.0.395 / 6.4.0.511 yjlee168 2014-02-02 07:54
    - Negative variance component ElMaestro 2014-02-01 16:31
      - Negative variance component yjlee168 2014-02-01 17:47
        
        Just thinking loud ElMaestro 2014-02-01 19:02
        
        All models are wrong… Helmut 2014-02-02 02:31
        
        another book for linear model yjlee168 2014-02-02 08:07
      - References Helmut 2014-02-02 02:19
        
        References ElMaestro 2014-02-02 09:56
    - Negative variance component – Chow/Liu d_labes 2014-02-03 09:02
      - Negative variance component – Chow/Liu ElMaestro 2014-02-03 10:22
        
        Variance components – Proc mixed d_labes 2014-02-03 11:58
        
        Variance components – Proc mixed ElMaestro 2014-02-03 12:58
        
        Variance components – Proc mixed 90% CIs d_labes 2014-02-03 13:16
        Variance components – Proc mixed Helmut 2014-02-03 14:14
        
        FDA code for non-replicate crossover? d_labes 2014-02-03 15:54
        
        Proc GLM rulez Helmut 2014-02-03 16:16
        
        Variance components – Proc mixed yjlee168 2014-02-03 20:43
        
        NOBOUND Helmut 2014-02-03 22:08
      - lm() or lme() for 2x2x2 study design? yjlee168 2014-02-03 20:22
        
        lm() or lme() for 2x2x2 study design? ElMaestro 2014-02-03 22:11
        
        lm() or lme() for 2x2x2 study design? yjlee168 2014-02-04 13:09
        
        bear for 2x2x2 study with negative variance components yjlee168 2014-02-05 19:12