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

jag009
★★★

NJ,
2012-04-21 00:28
(5181 d 18:41 ago)

Posting: # 8451
Views: 2,736

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

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

drgunasakaran1
★★

2012-04-21 09:46
(5181 d 09:23 ago)

@ jag009
Posting: # 8452
Views: 2,219

BE question: Immedidate Release Tablet for FDA

Post reply

❝ Innovator can be taken with or without food. --> This means a generic filing

❝ will reqire a fasting and a fed study?

Yes

❝ Innovator must be taken with food. --> This means a generic filing will only

❝ require a fed study?

No. For orally administered, immediate release products labeled to be taken only with food, fasting and fed studies are recommended, except when serious adverse events are anticipated with fasting administration. In these cases, FDA recommends that applicants conduct only a fed study; a fasting study is not recommended.Reference

❝ Innovator must be taken under fasted conditions. --> This means a generic filing will only require a fasting study?

Yes

—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

jag009 ★★★ NJ, 2012-04-23 17:59 (5179 d 01:09 ago) @ drgunasakaran1 Posting: # 8456 Views: 2,106	BE question: Immedidate Release Tablet for FDA Post reply
	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