Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-02-21 15:42 CET (UTC+1h)
 

Enlighten me please [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-09-07 06:16  - Posting: # 17790
Views: 1,097

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
17,924 Posts in 3,815 Threads, 1,119 registered users;
34 users online (1 registered, 33 guests).

For every expert there is an equal and opposite expert.    Arthur C. Clarke

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