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Registeradministration of Orally disintegrating tablet in BEstudy [Regulatives / Guidelines]
Dear all,
This is regarding administration of Orally disintegrating tablet (ODT) in BE study. As per guideline ODT should disintegrates rapidly, usually within a matter of seconds (usually 30 second), when placed upon the tongue. In case the product does not disintegrates within the specified time or case where the reference product is disintegrating & test product does not, how do proceed for dosing. can we administer the tablet with water or can we instruct volunteers to suck the tablet and then swallow it. will this affect the PK ?? please share your view.
chak
This is regarding administration of Orally disintegrating tablet (ODT) in BE study. As per guideline ODT should disintegrates rapidly, usually within a matter of seconds (usually 30 second), when placed upon the tongue. In case the product does not disintegrates within the specified time or case where the reference product is disintegrating & test product does not, how do proceed for dosing. can we administer the tablet with water or can we instruct volunteers to suck the tablet and then swallow it. will this affect the PK ?? please share your view.
chak
Complete thread:
- administration of Orally disintegrating tablet in BEstudychak 2007-12-17 11:07
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- administration of Orally disintegrating tablet in BEstudy kasi 2007-12-21 08:16
- administration of Orally disintegrating tablet in BEstudy chak 2007-12-21 15:52
- administration of Orally disintegrating tablet in BEstudy Virendra Patel 2007-12-26 14:10
- administration of Orally disintegrating tablet in BEstudy kasi 2007-12-21 08:16
Ing. Helmut Schütz