Bioequivalence and Bioavailability Forum • FDA: In-Vitro Alcohol testing of modified release product

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

posted by jag009 – NJ, 2012-05-16 18:22 (5138 d 12:42 ago) – Posting: # 8577
Views: 2,837

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

Complete thread:

FDA: In-Vitro Alcohol testing of modified release productjag009 2012-05-16 16:22 [Regulatives / Guidelines]
- FDA: In-Vitro Alcohol testing of modified release product Shuanghe 2012-05-17 10:08