Bioequivalence and Bioavailability Forum • Tmax differences in BE studies

Tmax differences in BE studies [Regulatives / Guidelines]

posted by jag009 – NJ, 2012-10-15 18:23 (5004 d 05:47 ago) – Posting: # 9417
Views: 5,198

Hi everyone,

Just some monday morning thoughts (US EST time)... Does anyone have experience with studies whereby the test and reference products were bioequivalent but Tmax values were very different, i.e. T=6 hrs, R=12 hrs, p<0.05? Lets say both sample size (>24) and Sampling time (hourly) were sufficient.

Any roadblocks from regulatory agency (US, Europe, etc.)

Thanks
John

Complete thread:

Tmax differences in BE studiesjag009 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