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

posted by anky1212 – India, 2018-05-31 13:37 (1336 d 08:17 ago) – Posting: # 18831
Views: 1,410


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:

 Admin contact
21,854 posts in 4,573 threads, 1,554 registered users;
online 9 (0 registered, 9 guests [including 9 identified bots]).
Forum time: Wednesday 20:54 CET (Europe/Vienna)

The real purpose of the scientific method is to make sure
nature hasn’t misled you into thinking you know something
you actually don’t know.    Robert M. Pirsig

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz