Bioequivalence and Bioavailability Forum 03:30 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

specific guidelines for psychotropic [Regulatives / Guidelines]

posted by mittyri - Russia, 2018-03-10 08:38  - Posting: # 18519
Views: 825

Dear Norah,

» is there any specific recommendation for BE studies concerning psychotropic ? for exmple for quetiapine should we use the less existing dose (for safety reasons) or we can use the higher dose ??

Did you get a chance to look into EMA PKWP Q&A?
There are some useful sentences regarding Quetiapine XR in section 14


Edit: Document linked. [Helmut]

Kind regards,
Mittyri

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,698 posts in 3,983 threads, 1,236 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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