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

posted by MaggieSantos - Portugal, 2017-04-26 18:20  - Posting: # 17271
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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

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