Sodium Valproate .... NTI? [Regulatives / Guidelines]

posted by hari emmadi – India, 2016-09-21 12:19 (3066 d 20:32 ago) – Posting: # 16655
Views: 2,393

Dear All,

Greetings....

We are planning to conduct bioequivalence study of sodium valproate crushable tablets 100 mg for TGA submission. Sodium valproate is CNS category of drug. In view of this, we would like to know whether this drug falls under category of narrow therapeutic index (NTI) or not?

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