Russian «Экс­пер­тами» and their hobby [Regulatives / Guidelines]

posted by Artem Gusev  – Russia, Moscow, 2017-05-02 18:13 (2638 d 23:32 ago) – Posting: # 17292
Views: 30,228

Hi, Helmut, Mittyri and ELMaestro!

Thanks for alot of usefull information!

I've made some calculation with the models from your post. BE Study with 44 subj (2 groups by 22 sbj) in Phoenix 6.4 (Formulation=Treatment, FF = Cmax/AUC).

Step 1.

Model Fixed Effects: Group+Sequence+Formulation+Group*Sequence+Group*Period+Group*Formulation.
Model Random Effects: Subject(Group*Sequence).

Partial Test:

Dependent     Hypothesis          Numer_DF   Denom_DF     F_stat        P_value
Ln(Cmax)      Group*Formulation       1      39.658597    0.027673298   0.86872445
Ln(AUClast)   Group*Formulation       1      39.208625    0.5880992     0.44774829
Ln(FF)        Group*Formulation       1      40.02772     0.064521326   0.80078777


P_value is good, but is this normaly that DF is not integer?

Step 2.

Model Fixed Effects: Group+Sequence+Formulation+Group*Sequence+Group*Period.
Model Random Effects: Subject(Group*Sequence).

Partial Test:

Dependent    Hypothesis       Numer_DF  Denom_DF     F_stat       P_value

Ln(Cmax)     int              1         40.921725    11484.381    0
Ln(Cmax)     Group            1         40.93824     0.88167054   0.35325184
Ln(Cmax)     Sequence         1         40.921725    0.18361757   0.67052981
Ln(Cmax)     Formulation      1         40.672472    0.046689365  0.83000761
Ln(Cmax)     Group*Sequence   1         40.93824     0.25766245   0.61445462
Ln(Cmax)     Group*Period     2         40.655533    0.94380823   0.39750275
Ln(AUClast)  int              1         41.090066    8381.629     0
Ln(AUClast)  Group            1         41.094871    1.1907365    0.28153775
Ln(AUClast)  Sequence         1         41.090066    1.4454616    0.23614044
Ln(AUClast)  Formulation      1         40.206255    2.9963913    0.091118919
Ln(AUClast)  Group*Sequence   1         41.094871    0.65923753   0.42150764
Ln(AUClast)  Group*Period     2         40.202418    0.41157679   0.66536478
Ln(FF)       int              1         40.650657    139.60377    1E-14
Ln(FF)       Group            1         40.662987    0.54340035   0.46525932
Ln(FF)       Sequence         1         40.650657    3.1149598    0.085088655
Ln(FF)       Formulation      1         40.989423    1.0744673    0.30601523
Ln(FF)       Group*Sequence   1         40.662987    0.75424068   0.39023396
Ln(FF)       Group*Period     2         40.969735    1.9475433    0.15560361


P_value is also acceptable, but is this normaly that DF here is also not integer?

Best Regards,
Artem

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