Oral Dispersible Tablet BE study USFDA submission [Regulatives / Guidelines]

posted by jag009  – NJ, 2018-04-13 21:23 (1292 d 07:35 ago) – Posting: # 18680
Views: 1,810

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...

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