Bioequivalence and Bioavailability Forum • Phoenix WNL to handle 2x2 crossover study with multip group

Phoenix WNL to handle 2x2 crossover study with multip group [Software]

posted by zan – US, 2014-06-28 01:29 (3951 d 04:37 ago) – Posting: # 13161
Views: 29,328

Hi All,
I am working on a 2x2 crossover BE study with large N (N=54). Due to limited clinical capacity the site separated subjects into two dosing groups (N=27 each). I have come across several discussion threads in the forum regarding the use of SAS model to deal with this issue, however, I would like to see how is this modeled correctly in Phoenix Winnonlin 6.3 as I only have WNL available.
Per FDA guidance the model should reflect that the periods in the first group are different from the periods in the second group. I immediately have two thoughts about this:

is it acceptable to just assign 4 periods to the 4 dosing days? If so,
In the model specification: Treatment+Sequence+Period
and in the variance structure--Random effect: Subject(Sequence).
Is there any issue with this approach? It looks to me these periods are independent occasions, which might not really separate each two periods for the same group.
Can we still keep these 2 periods and add a Group term to these subjects (eg. Group 1 and Group 2)?. If so, in the model specification:
Treatment+Sequence+Period+Group
but in the variance structure, I dont know what is appropriate to be added in the Random effect field. Should it be Subject(Sequence*Group).

I wanted to make sure I choose the correct procedure in PHX Winnonlin so that when FDA asks whether we properly deal with the issue with multiple dosing groups.

Really appreciate for any help.

Zan

Edit: Category changed. [Helmut]

Complete thread:

Phoenix WNL to handle 2x2 crossover study with multip groupzan 2014-06-27 23:29
- Phoenix WNL to handle 2x2 crossover study with multip group ElMaestro 2014-06-28 23:23
- Group effect commonly not relevant Helmut 2014-06-30 16:55
  - Group effect in 2x2 BE study zan 2014-06-30 19:18
    - Group effect in 2x2 BE study ElMaestro 2014-06-30 20:36
    - To pool or not to pool Helmut 2014-06-30 20:51
      - To pool or not to pool zan 2014-06-30 21:02
        
        To pool or not to pool Helmut 2014-06-30 21:38
        
        To pool or not to pool zan 2014-06-30 21:46
        
        To pool or not to pool Helmut 2014-06-30 22:22
        
        To pool or not to pool zan 2014-07-01 01:15
        
        Partial vs. sequential tests in WNL Helmut 2014-07-01 12:26
        
        Partial vs. sequential tests in WNL zan 2014-07-01 18:03
        
        Loosing patience Helmut 2014-07-01 18:23
        
        To pool or not to pool ElMaestro 2014-06-30 22:11
        
        To pool or not to pool zan 2014-07-01 01:18
        To pool or not to pool zan 2014-07-02 19:56
        
        To pool or not to pool ElMaestro 2014-07-03 00:17
        
        To pool or not to pool zan 2014-07-03 00:36
        
        sequence- / period effect #666 Helmut 2014-07-03 10:05
  - Group effect commonly not relevant AngusMcLean 2014-07-06 16:19
    - Group effect commonly not relevant Helmut 2014-07-06 20:32
      - Group effect commonly not relevant AngusMcLean 2014-07-06 22:52
        
        Group effect commonly not relevant Helmut 2014-07-06 23:57
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 15:04
        
        PHX: Parameter mapping Helmut 2014-07-07 15:45
        
        PHX: Parameter mapping Shuanghe 2014-07-07 17:35
        
        Great hint! Helmut 2014-07-07 17:54
        PHX: Parameter mapping AngusMcLean 2014-07-07 20:49
        
        PHX: Parameter mapping AngusMcLean 2014-07-07 18:46