Proportional or non proportional products [Regulatives / Guidelines]

posted by Mithu – India, 2019-08-27 07:18  – Posting: # 20524
Views: 210

Hello All,

Recently we had conducted study on narrow therapeutic drug. We had conducted fasting and Fed study on higher strength and only fasting study on lower strength due to lower strength is not dose proportional.

Now agency is asking rational for not performing fed study on lower strength. Here i need to know does any of the agency document speak about how to handle non proportional strength especially for narrow therapeutic products?

usually whenever agency asked to conduct study on lower strength, they ask only Fasting study in OGD (may be they are asking to conduct study on lower strength along with higher, due to non proportional) but i could not get any kind of clarity in any of the agency guideline for non proportional products.

Please suggest me if i am missing to review any published guideline by agency on this matter.

Regards,

Mithu.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,818 posts in 4,201 threads, 1,361 registered users;
online 9 (0 registered, 9 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 19:03 CEST

If I find 10,000 ways something won’t work, I haven’t failed.
I am not discouraged, because every wrong attempt discarded
is another step forward.    Thomas Alva Edison

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5