Bioequivalence and Bioavailability Forum • Dissolution

Dissolution [Dissolution / BCS / IVIVC]

posted by jag009 – NJ, 2014-08-25 17:19 (3891 d 00:38 ago) – Posting: # 13429
Views: 7,878

Hi Dr. Dan,

In Europe it's three medium for IR drug? For FDA they only asked for 1 medium and that's 1.2N HCl as per USP. USP specs listed no less than 75% in 60 mins. We submitted our drug's release spec based on USP spec disso (NLT 75 in 60 mins) and FDA came back with no less than 80% in 30 min.

John

Complete thread:

Dissolution jag009 2014-08-22 16:47
- Dissolution Dr_Dan 2014-08-22 19:27
  - Dissolutionjag009 2014-08-25 15:19
- Dissolution luvblooms 2014-08-26 06:41
  - Dissolution jag009 2014-08-26 17:33
    - Dissolution luvblooms 2014-08-28 08:21
      - Dissolution Samaya B 2014-09-01 07:48
        
        Dissolution luvblooms 2014-09-01 14:09
        
        Dissolution Samaya B 2014-09-04 06:54