Bioequivalence and Bioavailability Forum

S×F variance [General Statistics]

posted by jag009 – NJ, 2014-12-24 17:21 (3846 d 17:57 ago) – Posting: # 14165
Views: 43,450

Hi Angus,

Of course the Concerta BE studies will not be RSABE based since the SwRs are all less than 0.294. So for partial AUCs + Cmax we will go through the ABE routine and conclude based on 80-125% CI. Then Helmut's suggestion above can be used to evaluate the 2nd criteria. The 2nd criteria (seems to me) is IBE/PBE based and I have no clue if you can get the info from the ABE routine. Personally I just don't see how one can fail the 2nd criteria (in my thinking) but then you have to demonstrate both... The 95% UCB I believe is for FDA to collect data, they probably want it for their own use.

Hope I answered your question.

P.S. I still don't understand the email you got from Ana regarding the computation of S2D from the G Matrix. If I recall correctly, she said to use the between subject variances of T & R + the between subject covariance for T & R???? See post :confused:

Happy Holidays!

John

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 variancejag009 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: Followup AngusMcLean 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 [General Sta­tis­tics]

Complete thread:

S×F variance [General Statistics]