Post by mittyri, 2014-08-28 19:09:
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?