Bioequivalence and Bioavailability Forum • OROS residence time

OROS residence time [Design Issues]

posted by Helmut – Vienna, Austria, 2012-09-14 15:58 (5032 d 08:13 ago) – Posting: # 9220
Views: 7,065

Hi ABE1580!

❝ Will it be possible to keep an option: "If the subject does not have at least one bowel movement a day, the plasma samples will not be analysed and the subject will be excluded from the study"

Again this does not make sense. Three defecations per day to one per three days are normal physical conditions. Keep in mind that BE should reflect what is stated in the label. Does the label state “If you defecate less frequently than once a day, see your physician”?

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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 timeHelmut 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 time Ohlbe 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