Bioequivalence and Bioavailability Forum 20:39 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

oral powder with water acceptable? [Regulatives / Guidelines]

posted by chris089 - Munich, Germany, 2018-04-16 13:43  - Posting: # 18687
Views: 1,320

Hello,

We have developed an oral powder for which we need to show BE to an existing tablet. I have inherited the results of a (narrowly) failed two-way BE study where the powder was administered without water and the reference with water. We have reasons to believe that the powder administered with water, would be bioequivalent to the tablet, and while it would not be as sexy marketing-wise as the intake without water, we are considering a second study where test and reference are taken with water.

Does anybody have experience, if the regulatory agencies (EU, free choice of RMS) would accept these results if only administration with water is claimed in the SmPC?

I know, that an oral powder is treated similarly to an ODT (PKWP Q&A). THE Guideline recommends a 3-period study (we would have 2x2, but should be OK), but there is no information on the consequence, if BE w/ water is demonstrated, but BE w/o water fails. Does this mean, that the whole product is considered not bioequvalent, or just that you cannot claim the application w/o water?
The famous last paragraph says "recommended use of the product", which I translate as "according to the SmPC".

Maybe it's a stupid question, but I'm new to the business. I have read the previous 1000 questions on water, but AFAIK this has not been discussed yet.

Best,
Christian

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,782 posts in 4,002 threads, 1,256 registered users;
online 12 (0 registered, 12 guests [including 12 identified bots]).

[…] our greatest mistake would be to forget that data
is used for serious decisions in the very real world,
and bad information causes suffering and death.    Ben Goldacre

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