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

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

posted by jag009 – NJ, 2012-04-21 00:28 (5184 d 02:01 ago) – Posting: # 8451
Views: 2,747

Hi everyone,

For immediate release generic products, is it required to do both a fast and a food effect studies?

Example:

Innovator can be taken with or without food. --> This means a generic filing
will reqire a fasting and a fed study?
Innovator must be taken with food. --> This means a generic filing will only
require a fed study?
Innovator must be taken under fasted conditions. --> This means a generic filing will only require a fasting study?

Thanks

John

Complete thread:

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