Bioequivalence and Bioavailability Forum • CR?

CR? [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-10-16 23:22 (5005 d 13:12 ago) – Posting: # 9426
Views: 4,585

Hi Helmut,

❝ Yep. Luv nonparametrics. What do you mean by “we had to show that Tlag was not significantly different …”? In the US? Surprise.

A long long time ago (2000s) in my previous life we were developing a generic of a DR product which is designed to be given in the evening to have morning effect. The drug has a specific Tlag which FDA required us to meet in addition to BE criteria.

John

Complete thread:

Tmax differences in BE studies jag009 2012-10-15 16:23
- Delayed release? Helmut 2012-10-15 16:41
  - Delayed release? jag009 2012-10-15 19:38
    - CR? Helmut 2012-10-15 19:59
      - CR? Ohlbe 2012-10-15 22:54
        
        t75%, HVD Helmut 2012-10-16 14:06
      - CR?jag009 2012-10-16 21:22