Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Back to the forum  2018-06-22 18:53 CEST (UTC+2h)

Enlighten me please [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-09-07 06:16  - Posting: # 17790
Views: 1,609

Hi ElMaestro,

» Hi Jag,I am sure that unless you find a really good reason buried in the material on the originator available via FOI the reason is going to be very hard to identify. :-|

Even in the NDA the levels of all three analyte plus another metabolite (which FDA doesn't want to see) were reported...

Oh well...
J

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,418 posts in 3,912 threads, 1,173 registered users;
online 19 (1 registered, 18 guests [including 10 identified bots]).

The greatest shortcoming of the human race is our inability
to understand the exponential function.    Albert Bartlett

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