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

posted by jag009  – NJ, 2014-12-05 20:57 (2393 d 01:23 ago) – Posting: # 13991
Views: 12,850

(edited by jag009 on 2014-12-05 21:12)

Hi everyone,

Question regarding the sub*Form interaction variance test required for Concerta draft guidance...

"Subject-by-formulation interaction variance, σ2D2I-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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