Bioequivalence and Bioavailability Forum • Using the Variability of IR for MR formulation

mittyri
★★

Russia,
2014-08-28 21:09
(4320 d 16:39 ago)

Posting: # 13441
Views: 6,062

Using the Variability of IR for MR formulation [Power / Sample Size]

Dear All,

I'm having some discussion with colleagues on the question of CV_IR usage (from published assessment reports Test_IR vs. Reference_IR) for MR formulation bioequvalence study (Test_MR vs. Reference_MR 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 CV_intra depends on API as well as formulation (and many other factors).
Am I right?

—
Kind regards,
Mittyri

ElMaestro ★★★ Denmark, 2014-08-28 21:33 (4320 d 16:15 ago) @ mittyri Posting: # 13442 Views: 4,856	Using the Variability of IR for MR formulation Post reply
	Hi Mittyri, ❝ Am I right? Yes. As a reasonably good rule of thumb CV_MR>CV_IR for a given metric. — Pass or fail! ElMaestro

jag009 ★★★ NJ, 2014-08-29 06:09 (4320 d 07:39 ago) @ mittyri Posting: # 13443 Views: 4,842	Using the Variability of IR for MR formulation Post reply
	HI, ❝ Therefore CV_intra depends on API as well as formulation (and many other factors). ❝ Am I right? Correct, you have both API and formulation components which will increase the CV_intra. John