Posting: # 17271
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.
Posting: # 17290
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.