Results Analysis [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2014-07-08 10:08 (2705 d 08:59 ago) – Posting: # 13235
Views: 10,322

Hi unique_one,

Excellent example.

» Questions:
» 1. Primary reason for BE Failure?

Noone can tell. It might be a bioinequivalent product, or it might be a bioequivalent product. Your result cannot distinguish the two.

» 2. Do re-formulation would be needed?

If you think the two products are bioinequivalent, then obviously yes.
If you think the two products are bioequivalent with the estimated GMR reflecting true product performance, then you might not be able to afford the sample size necessary for another study in which case reformulation is necessary.
You might opt for a repeat study, too. You can probably assume any GMR within the CI's (although a GMR close to the some of the extremes are likely a bit unwise and unethical. Hötzi rants are a possibility).

There is little literature covering such situations, but I know people are working on it - publication within 12 months or so...:-D

Pass or fail!

Complete thread:

 Admin contact
21,785 posts in 4,556 threads, 1,547 registered users;
online 7 (0 registered, 7 guests [including 7 identified bots]).
Forum time: Friday 18:08 CET (Europe/Vienna)

A drug is that substance which, when injected into a rat,
will produce a scientific report.    Anonymous

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz