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RegisterOral Dispersible Tablet BE study USFDA submission [Regulatives / Guidelines]
Hi,
» Till now , FDA has not issued the general invivo BE study recommendation to conduct the ODT
I did a bunch of them a few years back but ours were NDAs (505b2s, ODTs vs reg tablets). Tablet on tongue, subject can't chew but can "suck" (you know, the small movement of your tongue like when you swallow something) on the tablet. After 10 or 30 seconds (don't remember details) check mouth. Once everything is disappear, then we give water...
» Till now , FDA has not issued the general invivo BE study recommendation to conduct the ODT
I did a bunch of them a few years back but ours were NDAs (505b2s, ODTs vs reg tablets). Tablet on tongue, subject can't chew but can "suck" (you know, the small movement of your tongue like when you swallow something) on the tablet. After 10 or 30 seconds (don't remember details) check mouth. Once everything is disappear, then we give water...
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 submissionjag009 2018-04-13 21:23
- Oral Dispersible Tablet BE study USFDA submission anky1212 2018-05-31 13:37
- Oral Dispersible Tablet BE study USFDA submissionjag009 2018-04-13 21:23
Ing. Helmut Schütz