Bioequivalence and Bioavailability Forum

S×F variance [General Statistics]

posted by AngusMcLean – USA, 2014-12-24 18:50 (3843 d 05:02 ago) – Posting: # 14167
Views: 43,508

Hello John: Best Wishes for the festive season.

❝ Of course the Concerta BE studies will not be RSABE based since the SwRs are all less than 0.294.

What makes you say that? Don't you think like Ambien the first one> 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.

Could you define 2 nd criteria ..do you mean sigma D² and the upper CB?...yes? steps 3 and 4 in the Guidance.

I am saying do we still have to evaluate the new criteria if we have shown that RSABE does not apply? That is one question I have.

❝ 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.

I agree. I was over there recently 30 minutes from here and we got questions like "what are your thoughts....." they want to use your thoughts and your data to assist them with the review process

❝ Hope I answered your question.

Please see above and clarify.

❝ 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:

Your recollection of the email is correct; she is telling you to use the G matrix components and I spelled out the calculation. I think you do understand it, but you are thinking that it is not correct for application to RSABE worksheet.. Anna is not a statistical programmer. I am not sure how to follow up on that. There is a problem here.

he only thing I can think of is in the case of replicate study design when Swr is <0.294 then reference scaling is not applied. You use average BE then at that point you use Ana's formula from her email for calculation sigmaD² and you do not use the RSABE workflow to calculate sigmaD²

Wha do think of that

Please don’t open new posts all the time. You an edit (i.e., also add sumfink) wihin 24 hours. THX. [Helmut]

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 varianceAngusMcLean 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]