Bioequivalence and Bioavailability Forum

Update: S×F variance test [Regulatives / Guidelines]

posted by jag009 – NJ, 2014-12-22 21:19 (3852 d 18:42 ago) – Posting: # 14138
Views: 13,535
(edited on 2014-12-23 04:44)

Hi Angus,

❝ John: what I did was ran the RSABE template with the EMEA data: first ABE is evaluated prior to RSABE in Phoenix.

So you followed the template which Helmut generated for Phoenix (or his instruction in calculating RSABE)?

I don't think you should look at the ABE analysis but instead look through the RSABE part of the worksheet and results. The RSABE part of the worksheet will give you the within-subject variances for T and R and I still believe the within-subject variance for I (or so called Ilat in the SAS code) is obtained from there also (and you will also get the df there). I think that path is how FDA wants our conclusion to arrive at.

Email me (you know how right) and I will give you more info. Maybe then we can see if we can come to an agreement before going further.

John

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Complete thread:

Concerta Guidance: Sub x Form interaction variance test jag009 2014-12-05 20:57 [Regulatives / Guidelines]
- Concerta Guidance: Sub x Form interaction variance test AngusMcLean 2014-12-06 01:28
  - Concerta Guidance: Sub x Form interaction variance test Helmut 2014-12-06 01:53
    - Concerta Guidance: Sub x Form interaction variance test jag009 2014-12-07 20:58
      - Concerta Guidance: S×F variance test AngusMcLean 2014-12-08 01:35
        
        Concerta Guidance: S×F variance test Helmut 2014-12-08 14:12
        
        Update: S×F variance test jag009 2014-12-08 17:40
        
        Update: S×F variance test AngusMcLean 2014-12-08 18:09
        
        EMA’s dataset I Helmut 2014-12-08 18:18
        
        EMA’s dataset I AngusMcLean 2014-12-08 19:55
        
        Update: S×F variance test jag009 2014-12-08 20:41
        
        Update: S×F variance test AngusMcLean 2014-12-08 18:18
        
        Question jag009 2014-12-10 17:01
        
        Question AngusMcLean 2014-12-10 18:34
        
        Update: S×F variance test kumarnaidu 2014-12-09 06:48
        
        Update: S×F variance test jag009 2014-12-09 15:16
        
        Update: S×F variance test AngusMcLean 2014-12-09 17:47
        
        Update: S×F variance test jag009 2014-12-09 18:01
        
        Update: S×F variance test AngusMcLean 2014-12-09 18:30
        
        Update: S×F variance test jag009 2014-12-18 15:31
        
        Update: S×F variance test AngusMcLean 2014-12-18 16:12
        
        Update: S×F variance test jag009 2014-12-22 17:28
        
        Update: S×F variance test AngusMcLean 2014-12-22 19:32
        
        Update: S×F variance testjag009 2014-12-22 20:19
        
        Update: S×F variance AngusMcLean 2014-12-22 20:45
        
        Update: S×F variance jag009 2014-12-22 20:51
        
        Update: S×F variance AngusMcLean 2014-12-22 21:10
        Update: S×F variance AngusMcLean 2014-12-22 21:36
        
        Update: S×F variance jag009 2014-12-22 22:18
        
        Update: S×F variance AngusMcLean 2014-12-22 23:26
        
        Update: S×F variance jag009 2014-12-23 04:43
        
        Update: S×F variance AngusMcLean 2014-12-23 15:24
        
        Update: S×F variance test AngusMcLean 2014-12-09 21:03
        
        Coding Helmut 2014-12-09 18:49
        
        working.... jag009 2014-12-09 22:24
- Concerta Guidance: S×F variance test ElMaestro 2014-12-06 11:12
  - Concerta Guidance: S×F variance test AngusMcLean 2014-12-07 14:32
    - Concerta Guidance: S×F variance test ElMaestro 2014-12-07 18:08
      - Concerta Guidance: S×F variance test AngusMcLean 2014-12-07 23:13
        
        Concerta Guidance: S×F variance test ElMaestro 2014-12-08 12:25
        
        Concerta Guidance: S×F variance test nobody 2014-12-08 13:44
        Concerta Guidance: S×F variance test AngusMcLean 2014-12-08 14:03
        
        Concerta Guidance:S×F variance test nobody 2014-12-08 14:32

Update: S×F vari­­ance test [Regulatives / Guidelines]

Complete thread:

Update: S×F variance test [Regulatives / Guidelines]