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Back to the forum  Query: 2018-04-25 00:58 UTC (UTC+2h)
 
Ramesh Ramalingam
Junior

India,
2018-04-13 08:52

Posting: # 18679
Views: 416
 

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

Dear All,

Till now , FDA has not issued the general invivo BE study recommendation to conduct the ODT (oral Dispersible Tablet) BE study. Could any one please suggest the drug administration procedure for oral Dispersible Tablet in bioequivalence study (If product specific BE study recommendation not issued).

:confused:

Regards,
Ramesh.R:
jag009
Hero

NJ,
2018-04-13 19:23

@ Ramesh Ramalingam
Posting: # 18680
Views: 304
 

 Oral Dispersible Tablet BE study USFDA submission

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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