Bioequivalence and Bioavailability Forum

jag009 ★★★ NJ, 2012-05-16 18:22 (5139 d 00:38 ago) Posting: # 8577 Views: 2,842	FDA: In-Vitro Alcohol testing of modified release product [Regulatives / Guidelines] Post reply
	Hi everyone, Does anyone have experience with the in-vitro EtOH testing on modified release drug product as per FDA for the assessment of dose dumping? Is it required to compare against the reference product? If so, is it based on f2? If the rate of in-vitro release in EtOH is not similar (i.e., faster but not the point of dose dumping) to that of the reference, then what? Thanks John

Shuanghe
★★

Spain,
2012-05-17 12:08
(5138 d 06:53 ago)

@ jag009
Posting: # 8579
Views: 2,392

FDA: In-Vitro Alcohol testing of modified release product

Post reply

❝ Is it required to compare against the reference product? If so, is it based on f2?

yes. If you go to FDA's guidance page looking for new individual BE guidance for MR product, almost all of them require this test and:

"Both test and reference listed drug (RLD) products should be tested accordingly and data should be provided on individual unit, means, range and %CV on all strengths."

❝ If the rate of in-vitro release in EtOH is not similar (i.e., faster but not the point of dose dumping) to that of the reference, then what?

check this link.

http://www.aapsj.org/abstracts/am_2008/aaps2008-001832.pdf

I hope this helps.

Shuanghe

—
All the best,
Shuanghe

FDA: In-Vitro Alcohol testing of modified release product [Regulatives / Guidelines]

FDA: In-Vitro Alcohol testing of modified release product