Russian «Экспертами» and their hobby [Regulatives / Guidelines]
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:
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:
P_value is also acceptable, but is this normaly that DF here is also not integer?
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
Best Regards,
Artem
Complete thread:
- Russian «Экспертами» and their hobby Helmut 2017-04-29 00:46 [Regulatives / Guidelines]
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57
- Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
- Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
- Some answers Helmut 2017-05-02 01:10
- Some answers ElMaestro 2017-05-02 09:04
- Example Helmut 2017-05-02 12:35
- Sensitivity of term? mittyri 2017-05-02 18:29
- Simulations Helmut 2017-05-05 14:38
- loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
- loosing specificity due to low sensitivity Helmut 2017-05-09 00:55
- loosing specificity due to low sensitivity mittyri 2017-05-08 23:28
- Loss in power Helmut 2017-05-06 17:31
- Interval between groups Helmut 2017-05-08 19:02
- IMP handling mittyri 2017-05-08 23:40
- IMP handling Helmut 2017-05-09 01:08
- IMP handling mittyri 2017-05-08 23:40
- Loss in power Helmut 2017-05-14 17:22
- Simulations Helmut 2017-05-05 14:38
- Some answers ElMaestro 2017-05-02 09:04
- No convergence in JMP and Phoenix WinNonlin Helmut 2017-05-25 15:26
- Ouch?!??? ElMaestro 2017-05-25 16:24
- Some answers Helmut 2017-05-02 01:10
- Let’s forget the Group-by-Treatment interaction, please! ElMaestro 2017-05-01 16:19
- Let’s forget the Group-by-Treatment interaction, please! Helmut 2017-04-30 13:54
- Russian «Экспертами» and their hobbyArtem Gusev 2017-05-02 16:13
- be careful with mixed models mittyri 2017-05-02 17:53
- be careful with mixed models Artem Gusev 2017-05-03 11:02
- p-value(s) in model 2 Helmut 2017-05-05 14:48
- be careful with mixed models mittyri 2017-05-02 17:53
- Russian «Экспертами» following the EEU GLs Helmut 2017-05-24 20:17
- Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
- Penalty for carelessness mittyri 2017-05-25 08:52
- Russian «Экспертами» following the EEU GLs Beholder 2017-05-25 10:43
- Russian «Экспертами» following the EEU GLs Mikalai 2018-01-04 10:43
- Belarus = member of the EEU Helmut 2018-01-04 13:08
- Belarus = member of the EEU Mikalai 2018-01-04 19:49
- Trying your model for EEU mittyri 2018-01-04 22:04
- Trying your model for EEU Helmut 2018-01-05 00:06
- help us to stop it, please... Astea 2018-01-10 12:09
- help us to stop it, please... Beholder 2018-01-10 12:49
- regulators convinced by science? d_labes 2018-01-10 15:15
- regulators convinced by science? Beholder 2018-01-10 17:14
- Чёрт побери! d_labes 2018-01-10 18:53
- regulators convinced by science? Astea 2018-01-10 19:10
- regulators convinced by science? Beholder 2018-01-10 17:14
- help us to stop it, please... Astea 2018-01-10 12:09
- Trying your model for EEU Helmut 2018-01-05 00:06
- Belarus = member of the EEU Helmut 2018-01-04 13:08
- Russian «Экспертами» following the EEU GLs Beholder 2017-05-24 22:37
- Low power of Group-by-Treatment interaction mittyri 2017-04-29 22:57