Bioequivalence and Bioavailability Forum

Concerta Guidance: Sub x Form interaction variance test [Regulatives / Guidelines]

posted by jag009 – NJ, 2014-12-05 21:57 (4220 d 03:59 ago) – Posting: # 13991
Views: 19,292

Hi everyone,

Question regarding the sub*Form interaction variance test required for Concerta draft guidance...

"Subject-by-formulation interaction variance, σ²_D=σ²_I-0.5*(σ²wt + σ²wr)

In Step 4..."As per APPENDIX A in the FDA 2001 bioequivalence guidance, the recommended allowance for σ²_D is 0.03."

They are referring to σ²_D value being no greater than 0.03 right? Can the number be negative, i.e, -0.06?

Thanks
John

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Complete thread:

Concerta Guidance: Sub x Form interaction variance testjag009 2014-12-05 20:57
- 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 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

Concerta Guidance: Sub x Form inter­action vari­ance test [Regulatives / Guidelines]

Complete thread:

Concerta Guidance: Sub x Form interaction variance test [Regulatives / Guidelines]