Bioequivalence and Bioavailability Forum • OROS residence time

OROS residence time [Design Issues]

posted by drsinghs – India, 2012-10-05 08:04 (5015 d 04:47 ago) – Posting: # 9311
Views: 6,950

Dear All,

I have some questions as below to add to this debate.

Assuming that the Tmax of the drug is 24 hours and both test and reference are OROS tablets.

Why can't I mention in the protocol upfront and exclude subjects who expel GIT before say 16 hours?
What is wrong in defining a criteria in protocol upfront to exclude the subjects who expel GITS after say 36 hours. This will be applicable to both treatments and Moreover as per my knowledge residence time in GIT is a subject variability and not formulation effect. In BE studies we test the formulations and not subject variability. Correct me if I am wrong.

Thanks & Regards,
drsinghs

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 timedrsinghs 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