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

posted by Ramesh Ramalingam  – India, 2018-04-13 12:52 (2261 d 07:01 ago) – Posting: # 18679
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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:

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