Lack of IntersubjectCV in PHX [Software]
Dear all,
According to this thread, we know that PHX does not output IntersubjectCV when the Var(Sequence*Subject) is negtive.
Using Ln() tranformation of PK data, I have verfified this using the data in the above thread. My results are identical to those obtained by our Helmut.
But when I analysis the above data using orignal Cmax data (none Ln transformed), I find that PHX does not output IntersubjectCV even the Var(Sequence*Subject) is positive. Some of my results using PHX WNL 7.0:
I don't know how to explain this? I notie that PHX WNL produces no Warning Messages in the output resluts.
But my manual calculation resluts are:
For Non-transformed data analysis, I use these formula:
InterCV = 100 * Sqr(SigmaS2) / LSMeanR
IntraCV = 100 * Sqr(SigmaE2) / LSMeanR
It's noted that here LSMeanR = Mean for None-Ln-transformed data.
they are cited from Page 153 of this book: Shein-Chung Chow and Jen-Pei Liu, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition. CRC Press. 2009.
So does PHX WNL miss this? or I am wrong? Can anyone help me to test of this by other software?
Can anyone help me to explain why WNL PHX doesn't calculate this for this dataset? or WNL PHX will never ouput this for BE analysis of None-Ln-transformed data and why?
Be sure, analysis of BE using Original Cmax data without Ln()-transformation.
Thank you for your help and clarification.
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I try this in WNL 5.1.1
It only outputs Var(Sequecen*Subject) and Var(Residual), but Inter CV and Intra CV are both not calculated when using None-transformed data. From the comparison of WNL 5.1.1 and PHX 7.0, it seems PHX is improved in this isssue, but still lack of IntersubjectCV.

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According to this thread, we know that PHX does not output IntersubjectCV when the Var(Sequence*Subject) is negtive.
Using Ln() tranformation of PK data, I have verfified this using the data in the above thread. My results are identical to those obtained by our Helmut.
But when I analysis the above data using orignal Cmax data (none Ln transformed), I find that PHX does not output IntersubjectCV even the Var(Sequence*Subject) is positive. Some of my results using PHX WNL 7.0:
Dependent Hypothesis DF SS MS F_stat P_value
Cmax Sequence 1 1056.5714 1056.5714 0.017626409 0.89657994
Cmax Sequence*Subject 12 719310.29 59942.524 1.3991004 0.28488402
Cmax Formulation 1 37889.286 37889.286 0.8843624 0.36555519
Cmax Period 1 88706.286 88706.286 2.0704667 0.17574474
Cmax Error 12 514123.43 42843.619
Cmax Var(Sequence*Subject) 8549.4524
Cmax Var(Residual) 42843.6190
Cmax Intrasubject CV 0.12677478
I don't know how to explain this? I notie that PHX WNL produces no Warning Messages in the output resluts.
But my manual calculation resluts are:
Parameter Item Value
Cmax Var(Sequence*Subject) 8549.4524
Cmax Var(Residual) 42843.6190
Cmax Inter-subject CV(%) 5.6632
Cmax Intra-subject CV(%) 12.6775
For Non-transformed data analysis, I use these formula:
InterCV = 100 * Sqr(SigmaS2) / LSMeanR
IntraCV = 100 * Sqr(SigmaE2) / LSMeanR
It's noted that here LSMeanR = Mean for None-Ln-transformed data.
they are cited from Page 153 of this book: Shein-Chung Chow and Jen-Pei Liu, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition. CRC Press. 2009.
So does PHX WNL miss this? or I am wrong? Can anyone help me to test of this by other software?
Can anyone help me to explain why WNL PHX doesn't calculate this for this dataset? or WNL PHX will never ouput this for BE analysis of None-Ln-transformed data and why?
Be sure, analysis of BE using Original Cmax data without Ln()-transformation.
Thank you for your help and clarification.
----------------------------------------------
I try this in WNL 5.1.1
It only outputs Var(Sequecen*Subject) and Var(Residual), but Inter CV and Intra CV are both not calculated when using None-transformed data. From the comparison of WNL 5.1.1 and PHX 7.0, it seems PHX is improved in this isssue, but still lack of IntersubjectCV.


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Complete thread:
- Lack of IntersubjectCV in PHXyicaoting 2017-09-01 11:09 [Software]
- CVs for untransformed data mittyri 2017-09-02 15:46
- CVs for untransformed data Helmut 2017-09-02 15:57
- CVs for untransformed data yicaoting 2017-09-02 17:50
- CVs for untransformed data Helmut 2017-09-02 19:20
- CVs for untransformed data yicaoting 2017-09-02 23:26
- CVs for untransformed data Helmut 2017-09-02 19:20
- CVs for untransformed data yicaoting 2017-09-02 17:50
- CVs for untransformed data yicaoting 2017-09-03 08:19
- CVs for untransformed data mittyri 2017-09-03 08:41
- CVs for untransformed data yicaoting 2017-09-04 11:35
- CVs for untransformed data mittyri 2017-09-03 08:41
- CVs for untransformed data Helmut 2017-09-02 15:57
- CVs for untransformed data mittyri 2017-09-02 15:46