Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-05-27 13:47 CEST (UTC+2h)
 
MaggieSantos
Junior

Portugal,
2017-04-26 18:20

Posting: # 17271
Views: 488
 

 Narrow Therapeutic Index- valproic acid and derivatives [Regulatives / Guidelines]

Dear colleagues,

Concerning valproic acid and derivatives is not consentaneous that it should be considered as a narrow therapeutic índex for bioequivalence purposes. I know that for FDA it is a NTI. Do you have information for EMA, for individual European countries and for other countries around the World.

Depending on the submission country, the BE interval will differ.
Please, feel free to comment.

I need the more information I can get.

Kind Regards

MaggieSantos
DavidManteigas
Regular

Portugal,
2017-05-02 12:07

@ MaggieSantos
Posting: # 17290
Views: 296
 

 Narrow Therapeutic Index- valproic acid and derivatives

Hi MaggieSantos,

In the absence of a product specific guideline and a list of NTI drugs in Europe, I would opt for requesting scientific advise if your position is that valproic acid is not a nti drug.

Regards,
David
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
16,926 Posts in 3,626 Threads, 1,030 registered users;
19 users online (0 registered, 19 guests).

EMEA. The European Medicines Evaluation Agency.
The drug regulatory agency of the European Union.
A statistician-free zone.    Stephen Senn

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