Bioequivalence and Bioavailability Forum • BE question: Immedidate Release Tablet for FDA

BE question: Immedidate Release Tablet for FDA [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-04-23 17:59 (5181 d 21:46 ago) – Posting: # 8456
Views: 2,113

Thanks Dr. Gunasakaran,

❝ ❝ Innovator can be taken with or without food. --> This means a generic filing will reqire a fasting and a fed study?

❝ Yes

Question for the above... The reason for running both fast and fed, is it to rule out potential food effect brought about by the non-active ingredients in the generic product?

Thanks

John

Complete thread:

BE question: Immedidate Release Tablet for FDA jag009 2012-04-20 22:28
- BE question: Immedidate Release Tablet for FDA drgunasakaran1 2012-04-21 07:46
  - BE question: Immedidate Release Tablet for FDAjag009 2012-04-23 15:59