Concerta Guidance: Sub x Form interaction variance test [Regulatives / Guidelines]
Hi everyone,
Question regarding the sub*Form interaction variance test required for Concerta draft guidance...
"Subject-by-formulation interaction variance, σ2D=σ2I-0.5*(σ2wt + σ2wr)
In Step 4..."As per APPENDIX A in the FDA 2001 bioequivalence guidance, the recommended allowance for σ2D is 0.03."
They are referring to σ2D value being no greater than 0.03 right? Can the number be negative, i.e, -0.06?
Thanks
John
Question regarding the sub*Form interaction variance test required for Concerta draft guidance...
"Subject-by-formulation interaction variance, σ2D=σ2I-0.5*(σ2wt + σ2wr)
In Step 4..."As per APPENDIX A in the FDA 2001 bioequivalence guidance, the recommended allowance for σ2D is 0.03."
They are referring to σ2D 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 [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
- EMA’s dataset I Helmut 2014-12-08 18:18
- Update: S×F variance test AngusMcLean 2014-12-08 18:18
- 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 jag009 2014-12-23 04:43
- Update: S×F variance AngusMcLean 2014-12-22 23:26
- Update: S×F variance jag009 2014-12-22 22:18
- Update: S×F variance jag009 2014-12-22 20:51
- Update: S×F variance AngusMcLean 2014-12-22 20:45
- Update: S×F variance test jag009 2014-12-22 20:19
- Update: S×F variance test AngusMcLean 2014-12-22 19:32
- Update: S×F variance test jag009 2014-12-22 17:28
- Update: S×F variance test AngusMcLean 2014-12-18 16:12
- Update: S×F variance test jag009 2014-12-18 15:31
- Update: S×F variance test AngusMcLean 2014-12-09 21:03
- Update: S×F variance test AngusMcLean 2014-12-09 18:30
- Coding Helmut 2014-12-09 18:49
- working.... jag009 2014-12-09 22:24
- Update: S×F variance test jag009 2014-12-09 18:01
- Update: S×F variance test AngusMcLean 2014-12-08 18:09
- Update: S×F variance test jag009 2014-12-08 17:40
- Concerta Guidance: S×F variance test Helmut 2014-12-08 14:12
- Concerta Guidance: S×F variance test AngusMcLean 2014-12-08 01:35
- Concerta Guidance: Sub x Form interaction variance test jag009 2014-12-07 20:58
- Concerta Guidance: Sub x Form interaction variance test Helmut 2014-12-06 01:53
- 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: S×F variance test ElMaestro 2014-12-08 12:25
- Concerta Guidance: S×F variance test AngusMcLean 2014-12-07 23:13
- Concerta Guidance: S×F variance test ElMaestro 2014-12-07 18:08
- Concerta Guidance: S×F variance test AngusMcLean 2014-12-07 14:32
- Concerta Guidance: Sub x Form interaction variance test AngusMcLean 2014-12-06 01:28