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Registersublingual tablets [Regulatives / Guidelines]
Hi!
Found a case of a (nearly) European Agency (UK
) granting a biowaiver for a chewable tablet, so apparently this type of formulation is considered closer to a conventional IR tablet, from regulatory perspective, although the 2010 EMA guidance on BE considers chewable tablets to be comparable to ODT, for which BE is required...
Found a case of a (nearly) European Agency (UK
) granting a biowaiver for a chewable tablet, so apparently this type of formulation is considered closer to a conventional IR tablet, from regulatory perspective, although the 2010 EMA guidance on BE considers chewable tablets to be comparable to ODT, for which BE is required...—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- sublingual tablets A-M-R 2013-02-04 08:34
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- sublingual tablets The Outlaw Torn 2013-02-04 08:52
- sublingual tablets drgunasakaran1 2013-02-06 08:40
- sublingual tabletsnobody 2014-11-21 11:33
Ing. Helmut Schütz