Bioequivalence and Bioavailability Forum

S×F variance: Followup [General Statistics]

posted by AngusMcLean – USA, 2015-02-22 18:25 (3344 d 20:02 ago) – Posting: # 14488
Views: 36,640
(edited by AngusMcLean on 2015-02-22 20:27)

John: I am not clear on the G matrix: At an earlier date I thought it was my salvation. I do not understand why it is not to be used. I do know that when I used the way I thought was appropriate it gave a ridiculous result. But then it is likely that I am not using in an appropriate way.

Both Linda and Ana are aware where we are but have not commented on how to use the G matrix. I have emailed them; Linda has expressed an interest in the work you did with Helmut and this thread.

Maybe the Prof. in Toronto can shed some light on this confusion: one thing I did do was create set of replicate ABAB MP data based on actual data I have and ran it in Phoenix. I have found it is difficult to fake suitable data so. It did run OK for bioequivalence, but as yet I have not pursued the steps 2, 3 and 4. The ad hoc changes I make on the existing template to give WT could be used. I need to figure out a way of modifying the template to have a standard template to produce WT and WR variance. It is difficult to do this if you did not write the code in the first place.

Regarding the wording of the recent MP Guidance then what I see is the Guidance has many people reviewing and editing it sentence by sentence. It is confusing in the part you focus on. I think they are not real sure what position to take and they want to get the sponsors to produce data for them, so that after they have enough data then they can formulate a rational policy. As you have said yourself I do not see them failing a submission on that part of the Guidance.

Angus

Complete thread:

S×F variance Helmut 2014-12-23 15:32 [General Statistics]
- S×F variance AngusMcLean 2014-12-23 16:32
  - S×F variance Helmut 2014-12-23 17:17
    - S×F variance AngusMcLean 2014-12-28 23:12
- S×F variance AngusMcLean 2014-12-23 20:56
- S×F variance jag009 2014-12-23 23:07
  - S×F variance AngusMcLean 2014-12-24 01:39
    - S×F variance jag009 2014-12-24 16:21
      - S×F variance AngusMcLean 2014-12-24 17:50
  - S×F variance AngusMcLean 2015-01-06 17:30
    - S×F variance: Followup jag009 2015-01-08 22:42
      - S×F variance: Followup AngusMcLean 2015-01-09 01:44
        
        S×F variance: Followup jag009 2015-01-12 16:53
        
        S×F variance: Followup AngusMcLean 2015-01-12 20:56
        
        S×F variance: 3rd opinion Helmut 2015-01-13 01:25
        
        S×F variance: 3rd opinion AngusMcLean 2015-01-13 20:13
        S×F variance: 3rd opinion AngusMcLean 2015-01-14 21:29
        
        S×F variance: 3rd opinion jag009 2015-01-14 23:00
        
        α vs. 1–α Helmut 2015-01-15 00:54
        
        α vs. 1–α jag009 2015-01-15 22:38
        
        α vs. 1–α Helmut 2015-01-16 00:13
        
        α vs. 1–α jag009 2015-01-19 20:09
        
        α vs. 1–α jag009 2015-01-19 16:02
        
        S×F variance: 3rd opinion AngusMcLean 2015-01-29 23:38
        
        S×F variance: Followup AngusMcLean 2015-01-30 23:24
        
        S×F variance: Followup jag009 2015-02-02 16:31
        
        S×F variance: Followup AngusMcLean 2015-02-02 17:22
        
        S×F variance: Followup jag009 2015-02-05 18:14
        
        S×F variance: Followup AngusMcLean 2015-02-06 01:39
        
        S×F variance: Followup jag009 2015-02-06 17:13
        
        S×F variance: Followup AngusMcLean 2015-02-06 19:36
        
        S×F variance: Followup jag009 2015-02-17 22:49
        
        S×F variance: Followup AngusMcLean 2015-02-19 23:25
        
        S×F variance: Followup jag009 2015-02-21 21:08
        
        S×F variance: FollowupAngusMcLean 2015-02-22 17:25
        
        S×F variance: Followup jag009 2015-02-23 16:58
- S×F variance AngusMcLean 2015-01-06 18:48
  - S×F variance jag009 2015-01-07 21:28
    - S×F variance Helmut 2015-01-08 16:10
      - S×F variance: Typo. jag009 2015-01-08 17:32
        
        S×F variance AngusMcLean 2015-01-08 18:51
        
        S×F variance jag009 2015-01-08 20:02
        
        S×F variance AngusMcLean 2015-01-08 20:27
        
        S×F variance jag009 2015-01-08 20:33

S×F vari­­ance: Follow­up [General Sta­tis­tics]

Complete thread:

S×F variance: Followup [General Statistics]