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RegisterOral Dispersible Tablet BE study USFDA submission [Regulatives / Guidelines]
Hi,
We did such studies in which we had allowed subject to wet the mouth by swallowing 20 mL of water directly before placing the investigational product on the tongue. After placing tablet on tongue, subject was asked not to chew or crush the tablet and after 30 seconds mouth was checked. We did not provided water as PIL mentioned use of tablet with or without tablet.
We did such studies in which we had allowed subject to wet the mouth by swallowing 20 mL of water directly before placing the investigational product on the tongue. After placing tablet on tongue, subject was asked not to chew or crush the tablet and after 30 seconds mouth was checked. We did not provided water as PIL mentioned use of tablet with or without tablet.
Complete thread:
- Oral Dispersible Tablet BE study USFDA submission Ramesh Ramalingam 2018-04-13 10:52 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Oral Dispersible Tablet BE study USFDA submission jag009 2018-04-13 21:23
- Oral Dispersible Tablet BE study USFDA submissionanky1212 2018-05-31 13:37
- Oral Dispersible Tablet BE study USFDA submission jag009 2018-04-13 21:23
Ing. Helmut Schütz