Bioequivalence and Bioavailability Forum

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

posted by Ramesh Ramalingam  – India, 2018-04-13 12:52 (1997 d 18:07 ago) – Posting: # 18679
Views: 2,527

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).



Regards,
Ramesh.R:

Complete thread:

• Oral Dispersible Tablet BE study USFDA submissionRamesh Ramalingam 2018-04-13 10:52 [Regulatives / Guidelines] 
  • Oral Dispersible Tablet BE study USFDA submission jag009 2018-04-13 21:23
    • Oral Dispersible Tablet BE study USFDA submission anky1212 2018-05-31 13:37