Bioequivalence and Bioavailability Forum • OROS residence time

OROS residence time [Design Issues]

posted by Ohlbe – France, 2012-10-05 12:40 (5014 d 02:29 ago) – Posting: # 9313
Views: 6,808

Dear drsinghs,

What if your drug has an effect on intestinal motility (either slowing it, or speeding it up) ? Let's say one of the two formulations is released faster in some subjects, leading to a higher Cmax, and a higher effect on motility. If you exclude those subjects who expel the tablet faster or slower, you will selectively exclude those subjects who will show a difference between test and reference !

Even if an effect on motility is not described as an effect or adverse event of your drug, I really doubt any regulator would accept such an exclusion.

Regards
Ohlbe

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Regards
Ohlbe

Complete thread:

OROS residence time ABE1580 2012-09-13 09:55
- OROS residence time Helmut 2012-09-13 14:28
- OROS residence time jag009 2012-09-13 17:34
  - OROS residence time Helmut 2012-09-13 17:45
    - OROS residence time jag009 2012-09-13 19:45
      - OROS residence time ABE1580 2012-09-14 07:56
        
        OROS residence time ABE1580 2012-09-14 11:14
        
        OROS residence time Helmut 2012-09-14 13:58
        
        OROS residence time jag009 2012-09-17 16:47
        
        OROS residence time Helmut 2012-09-17 16:56
    - OROS residence time jag009 2012-09-18 17:11
    - OROS residence time drsinghs 2012-10-05 06:04
      - OROS residence timeOhlbe 2012-10-05 10:40
        
        OROS residence time drsinghs 2012-10-05 12:14
        
        And where? Helmut 2012-10-05 13:34
        
        And where? drsinghs 2012-10-05 14:16
        
        And where? Ohlbe 2012-10-05 16:00
        
        And where? jag009 2012-10-12 23:05