SKR
☆    

2007-12-01 14:21
(6781 d 23:10 ago)

Posting: # 1349
Views: 5,710
 

 Group effect in Replicate Design [Design Issues]

Dear HS,

I would appreciate ur help in this regard. Here is a question regarding replicate design. As there are some logistic reasons, the replicate study has been conducted in two groups. I used the SAS code given in "FDA guidance Statistical Approaches to Establishing Bioequivalence" for ANOVA and CI calculation. How to test the group effect? which factors the ANOVA model should include?
Thanks in advance :-)
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2007-12-02 13:43
(6780 d 23:48 ago)

@ SKR
Posting: # 1350
Views: 3,910
 

 Group effect in Replicate Design

Dear SKR!

❝ […] How to test the group effect? which factors the ANOVA model should include?


IMHO you should add a Group and a Treatment by Group interaction term as fixed effects. See also this post.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
d_labes
★★★

Berlin, Germany,
2008-01-23 16:52
(6728 d 20:39 ago)

@ Helmut
Posting: # 1546
Views: 3,584
 

 Group effect in Replicate Design

Dear HS,

❝ IMHO you should add a Group and a Treatment by Group interaction term as fixed effects. See also this post.


in the linked post you do not recommend a group by period interaction.

How can we then interpret the paragraph VII A "Studies in multiple groups" in the FDA guidance
"... In particular, the model should reflect the fact that the periods for the first group are different from the periods for the second group. ...".

To my understanding this calls for group by period interaction.?

Regards,

D_Labes

Regards,

Detlew
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2008-01-23 18:02
(6728 d 19:30 ago)

@ d_labes
Posting: # 1549
Views: 3,771
 

 Group effect in Replicate Design

Dear D_Labes!

❝ ❝ […] See also this post.

❝ in the linked post you do not recommend a group by period interaction.

❝ How can we then interpret the paragraph VII A "Studies in multiple groups" in the FDA guidance

❝ "… In particular, the model should reflect the fact that the periods for the first group are different from the periods for the second group…".

❝ To my understanding this calls for group by period interaction.?


Please see also this post. But of course, this is just my personal opinion…

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
410 visitors (0 registered, 410 guests [including 26 identified bots]).
Forum time: 14:32 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5