Bioequivalence of ODT (Orodispersible Tablets) [Regulatives / Guidelines]

posted by drgunasakaran1  – 2016-01-02 19:52 (3324 d 11:11 ago) – Posting: # 15790
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Dear Dr Ripal,

❝ For bio equivalence of ODT tablets, should it be given with water or should it be placed on the tongue without water?


Kindly let us know the country of submission and molecule name.?
If it is Alprazolam ODT and intended country of submission is US FDA, the whole tablet should be placed on the tongue and allowed to disintegrate for 30 seconds. After 30 seconds, all subjects should consume 240 mL of water.

Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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