Bioequivalence and Bioavailability Forum • New MR formulation

hirenpharm
☆

Ahmedabad,
2007-04-01 16:50
(6618 d 16:06 ago)

Posting: # 609
Views: 3,223

New MR formulation [Regulatives / Guidelines]

Dear all,

We have developed new MR tablet for FDA submission, same is availabe in IR tablet.

As we know it will be registered as NDA after showing BE with IR in fast/fed and steady state condition as per guideline.

Query:
Whether we have to show 90% CI for Cmax in single dose fast/fed studies?
(For EU submission also)
In Steady state Cmax, Cmin and AUC is passing.

Please suggest.

—
Dr. Hiren Mehta

velupharm ☆ 2007-04-01 21:56 (6618 d 11:01 ago) @ hirenpharm Posting: # 610 Views: 2,541	New MR formulation Post reply
	Dear HirenPharm As per the general BA/BE guidelines of USFDA & definitions in Orange book as well as EMEA guielines on MR products(section 4), you need not show 90%CI for Cmax. Only the total systemic exposure (i.e) AUC & proof of claim for the release charecteristics of MR have to be shown. Hope this helps