Bioequivalence and Bioavailability Forum • Drugs of abuse

Drugs of abuse [Design Issues]

posted by cher0424 – China, 2014-12-18 05:54 (4207 d 06:29 ago) – Posting: # 14101
Views: 16,032

Hi Helmut

❝ ❝ One subject TCA show positive in the test. In this situation what should we do test again or exclude? if test again, what's the interval is proper?

❝

❝ If a positive result is part of the exclusion criteria – exclude the subject. Otherwise, why did you test for it and state it in the protocol? BTW, I never saw a protocol which allows retesting. Given the half-lives of TCAs likely you will get another positive result anyway.

You mean no retesting in drug abuse or other clinic exam also? I saw hematology can be retested.
TCA isn't listed in protocol, but can be test out in our drug abuse test card. So here is a pratical operated problem. The protocol writer didn't combine the reality with protocol. So all the things just refer to the protocol, then ignore the positive result of TCA?

Complete thread:

BE study inclusion & exclusion criteria cher0424 2014-12-16 01:30
- BE study inclusion & exclusion criteria Helmut 2014-12-16 14:53
  - BE study inclusion & exclusion criteria Ohlbe 2014-12-16 17:29
    - BE study inclusion & exclusion criteria cher0424 2014-12-17 02:19
      - Drugs of abuse Helmut 2014-12-17 14:42
        
        Drugs of abusecher0424 2014-12-18 04:54
        
        Stick to the protocol, but… Helmut 2014-12-18 14:02
    - BE study inclusion & exclusion criteria Helmut 2014-12-17 13:33
  - BE study inclusion & exclusion criteria cher0424 2014-12-17 02:02
    - BE study inclusion & exclusion criteria Helmut 2014-12-17 14:24
- BE study inclusion & exclusion criteria Ohlbe 2014-12-17 17:35
  - Smoking Helmut 2014-12-17 17:48
    - Thanks for solving out cher0424 2014-12-18 02:08
    - Smoking d_labes 2014-12-18 08:08
    - Smoking Mahesh M 2014-12-18 13:50
      - Smoking ElMaestro 2014-12-18 14:10
        
        Smoking Mahesh M 2014-12-19 07:14
        
        Smoking ElMaestro 2014-12-19 11:35