Log in
RegisterBetween vs Within [General Statistics]
Hello Mittyri and Helmut,
So you would assume that Residual Mean Squares (MS) as the denominator was used because nothing is explicitly stated? If Subject MS was used instead as the denominator, you think that they would probably mention it?
Is there any source or literature what to use as denominator when assessing Group*Treatment interaction? I cant find anything relevant. Nothing is mentioned about it in the new ICH M13A guideline: The group x treatment interaction term should not be included in the model. However, applicants should evaluate potential for heterogeneity of treatment effect across groups and discuss its potential impact on the study data, e.g., by investigation of group x treatment interaction in a supportive analysis and calculation of descriptive statistics by group.
I am wondering what to use as a denominator when testing the Group*Treatment interaction and how to support this decision with literature references when writing a report and answering to regulatory agencies.
Additionally, what if the significance between the denominator used differ?
Regards
BEQool
❝ It appears that the authors used the Residual Mean Squares (MS) as the denominator for the F-tests, rather than the Subject MS. This choice is not explicitly stated but seems likely based on the overall approach. Therefore, it's reasonable to assume that the interaction term Group*Formulation should also be tested against the Residual MS, not the Subject MS.
So you would assume that Residual Mean Squares (MS) as the denominator was used because nothing is explicitly stated? If Subject MS was used instead as the denominator, you think that they would probably mention it?
Is there any source or literature what to use as denominator when assessing Group*Treatment interaction? I cant find anything relevant. Nothing is mentioned about it in the new ICH M13A guideline: The group x treatment interaction term should not be included in the model. However, applicants should evaluate potential for heterogeneity of treatment effect across groups and discuss its potential impact on the study data, e.g., by investigation of group x treatment interaction in a supportive analysis and calculation of descriptive statistics by group.
I am wondering what to use as a denominator when testing the Group*Treatment interaction and how to support this decision with literature references when writing a report and answering to regulatory agencies.
Additionally, what if the significance between the denominator used differ?
Regards
BEQool
Complete thread:
- Group-by-Treatment Interaction: the final word? Helmut 2024-04-19 01:26 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Group-by-Treatment Interaction: FDA Helmut 2024-09-20 13:30
- Group-by-Treatment Interaction: the final word? BEQool 2024-10-03 15:09
- ANOVA of Model 1 Helmut 2024-10-03 15:33
- ANOVA of Model 1 BEQool 2024-10-03 16:08
- ANOVA of Model 1 Helmut 2024-10-04 10:11
- Between vs Within mittyri 2024-10-05 00:08
- Between vs WithinBEQool 2024-10-06 20:06
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-06 22:00
- Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-07 10:27
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-07 13:11
- Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-14 11:01
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-07 13:11
- Treatment-by-Group in PROC MIXED and PROC GLM? BEQool 2024-10-07 10:27
- Treatment-by-Group in PROC MIXED and PROC GLM? mittyri 2024-10-06 22:00
- Between vs WithinBEQool 2024-10-06 20:06
- Between vs Within mittyri 2024-10-05 00:08
- ANOVA of Model 1 Helmut 2024-10-04 10:11
- ANOVA of Model 1 BEQool 2024-10-03 16:08
- ANOVA of Model 1 Helmut 2024-10-03 15:33
Ing. Helmut Schütz