Bioequivalence and Bioavailability Forum • Fixed Dose Combination Products

joyjac
★

Philippines,
2007-03-23 09:47
(7023 d 04:38 ago)

Posting: # 597
Views: 4,727

Fixed Dose Combination Products [Design Issues]

Dear colleagues,

Is it possible to apply scaled ABE on one active drug ingredient identified as a highly variable drug/drug product based on a previous study and on published literature, but make use of the conventional ABE approach for the other active drug component identified as not highly variable? Of course this will be stated a priori in the protocol. Your insight on this would be appreciated. Thanks.

Helmut
★★★

Vienna, Austria,
2007-03-23 12:27
(7023 d 01:59 ago)

@ joyjac
Posting: # 598
Views: 3,862

Fixed Dose Combination Products

Post reply

Dear Joy,

IMHO there should be no problem with such an approach.
BTW, although I've never seen such a study, I think it's a great idea.
You are really creative!

If you want to perform your study for an application with the FDA, please note:

There is not guideline on HVDs/HVDPs,
FDA may want to see a minimum sample size (24 or 36?), and
I would suggest waiting for results of the next meeting of the ACPSCP on 02 May 2007.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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