Dabigatran EMA - product-specific guide [Regulatives / Guidelines]

posted by nobody – 2019-02-13 17:58 (623 d 19:15 ago) – Posting: # 19907
Views: 3,149

Hi again!

Just by chance I stumbled upon this here:

https://www.ema.europa.eu/en/dabigatran-etexilate-product-specific-bioequivalence-guidance

Have a look at the comments by the originator and the final guidance. OK, pH and dabigatran is an issue, but is it really sufficient that the originator writes some 15-20 lines of text (without any citation?) to introduce a rather complex study to the development of a generic? No data at all supporting this claim? And EMA just buys it? Are we back to the 1950's?

Or all data trade secrets? OMG... reminds me of some witch hunt before the inquisition started to introduce some legal procedures before the death penalty was imposed.



Sorry, too late for "edit", but this might be a clear case for a publication in the Journal "Well, trust us"...

http://www.sciencemag.org/careers/2012/02/ive-got-your-impact-factor-right-here

:-(


Edit: normally you should have been able to edit your message ? You have 24 hours to do so. No time limit for Mods and Admins, luckily :-) [Ohlbe]

Kindest regards, nobody

Complete thread:

Activity
 Admin contact
21,179 posts in 4,414 threads, 1,477 registered users;
online 5 (0 registered, 5 guests [including 2 identified bots]).
Forum time: Thursday 13:13 UTC (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5