Bioequivalence and Bioavailability Forum

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

posted by jag009 – NJ, 2014-12-22 18:28 (4203 d 23:15 ago) – Posting: # 14136
Views: 15,874

Hi Angus,

Before I go further, just want to clarify, did you go through the exercise 1) as per FDA's concerta guidance, calculating Iij, Tij, Rij, YijR, YijT etc etc and then obtain the within-subject variances for T and R in Phoenix?
2) Or you just threw the EMA dataset (ln-transformed) into Phoenix ABE routine and obtain #s from The G matrix output? I imagine you would say #2?

I don't think approach #2 will give the right answer and the d.f. which is needed to compute the 95% CB as per FDA instruction.

Helmut and I goofed around with both scenarios (in Phoenix, and I did in SAS) and the results were a bit amusing (I will let Helmut to summarize if he wants).

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 testjag009 2014-12-22 17:28
        
        Update: S×F variance test AngusMcLean 2014-12-22 19:32
        
        Update: S×F variance test jag009 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]