Bioequivalence and Bioavailability Forum • BE study inclusion & exclusion criteria

BE study inclusion & exclusion criteria [Design Issues]

posted by cher0424 – China, 2014-12-17 03:19 (4208 d 05:40 ago) – Posting: # 14090
Views: 16,360

❝ Well, not only ! The amount of blood collected during a BE trial is of the same order of magnitude as the volume taken during a blood donation. In the interest of subject safety, most CROs just replicate the usual timelines between two blood donations.

Your explain inspire me to think just only focus on BE study and here is one exclude criteria i quote from protocol
"Positive results for drugs of abuse (benzodiazepines, cocaines, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period."
why just include these six drugs, the thing is our drug test plate can test out tricyclic antidepressant (TCA) and Phencyclidine (PCP) also. 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?

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 criteriacher0424 2014-12-17 02:19
      - Drugs of abuse Helmut 2014-12-17 14:42
        
        Drugs of abuse cher0424 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