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

posted by anky1212 – India, 2018-05-31 13:37 (884 d 10:14 ago) – Posting: # 18831
Views: 1,266

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.

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