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RegisterBioequivalence of ODT (Orodispersible Tablets) [Regulatives / Guidelines]
Dear Dr Ripal,
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.
❝ 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.
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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
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
Complete thread:
- Bioequivalence of ODT (Orodispersible Tablets) Dr Ripal 2016-01-01 05:43 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Bioequivalence of ODT (Orodispersible Tablets)drgunasakaran1 2016-01-02 18:52
- Bioequivalence of ODT (Orodispersible Tablets) Dr Ripal 2016-01-04 09:39
- Crystal ball Helmut 2016-01-04 16:35
- Crystal ball Dr Ripal 2016-01-06 08:03
- Crystal ball Helmut 2016-01-04 16:35
- Bioequivalence of ODT (Orodispersible Tablets) Dr Ripal 2016-01-04 09:39
- Bioequivalence of ODT (Orodispersible Tablets)drgunasakaran1 2016-01-02 18:52
Ing. Helmut Schütz