Bioequivalence and Bioavailability Forum • Alcohol Dose Dumping: Requirments?

Alcohol Dose Dumping: Requirments? [Regulatives / Guidelines]

posted by jag009 – NJ, 2014-09-05 17:44 (4312 d 15:42 ago) – Posting: # 13462
Views: 9,814

Hi Bloom,

Don't they understand this statement from the guidance? "Due to a concern of dose dumping of drug from this drug product when taken with alcohol, the Agency currently requests that additional in vitro dissolution testing be conducted using various concentrations of ethanol in the dissolution medium"

It's a safety issue. You want to demonstrate that your product does not dose dump due to the coating being "damaged" by EtOH. So if RLD dose dumps and your BE product also dose dumps, you think FDA will give you the green light because your product is BE?

❝ ❝ Hmm... We did it for all strengths filed (as in test every strengths) and yes ours are dosage strength proportional... Maybe we were playing it safe?

❝

❝ This is what I proposed but again here people want to match each strength of test with each strength of reference. :smoke:

No I meant we did the EtOH test on all strengths, not just at the highest strength. I was against this but then again the RA wanted a safe passage.

John

Complete thread:

Alcohol Dose Dumping: Requirments? luvblooms 2014-09-04 09:47
- Alcohol Dose Dumping: Requirments? jag009 2014-09-04 20:23
  - Alcohol Dose Dumping: Requirments? luvblooms 2014-09-05 06:28
    - Alcohol Dose Dumping: Requirments? nobody 2014-09-05 08:47
    - Alcohol Dose Dumping: Requirments?jag009 2014-09-05 15:44
      - Alcohol Dose Dumping: Requirments? luvblooms 2014-09-10 06:25
        
        Alcohol Dose Dumping: Requirments? nobody 2014-09-10 10:31
        OGD's article in AAPS J may help Shuanghe 2014-09-10 11:39
        
        OGD's article in AAPS J may help luvblooms 2014-09-11 05:56
        
        OGD's article in AAPS J may help bharathi 2016-08-17 13:10