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RegisterUsing the Variability of IR for MR formulation [Power / Sample Size]
Dear All,
I'm having some discussion with colleagues on the question of CVIR usage (from published assessment reports TestIR vs. ReferenceIR) for MR formulation bioequvalence study (TestMR vs. ReferenceMR single dose).
I'm quite doubt that CV from bioequivalence IR study is a good idea. As I remember bioequivalence assesses similarity of absorption (product specific) – not elimination (drug specific)
Therefore CVintra depends on API as well as formulation (and many other factors).
Am I right?
I'm having some discussion with colleagues on the question of CVIR usage (from published assessment reports TestIR vs. ReferenceIR) for MR formulation bioequvalence study (TestMR vs. ReferenceMR single dose).
I'm quite doubt that CV from bioequivalence IR study is a good idea. As I remember bioequivalence assesses similarity of absorption (product specific) – not elimination (drug specific)
Therefore CVintra depends on API as well as formulation (and many other factors).
Am I right?
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Using the Variability of IR for MR formulationmittyri 2014-08-28 19:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Using the Variability of IR for MR formulation ElMaestro 2014-08-28 19:33
- Using the Variability of IR for MR formulation jag009 2014-08-29 04:09
Ing. Helmut Schütz