Bioequivalence and Bioavailability Forum • BE study inclusion & exclusion criteria

BE study inclusion & exclusion criteria [Design Issues]

posted by cher0424 – China, 2014-12-16 02:30 (3413 d 14:57 ago) – Posting: # 14074
Views: 14,125

Dear all:
Have a good day!
I have some queries concerning the rationale BE study inclusion & exclusion criteria.
what's the exactly impart to study when subjet abuse smoking ? and why donation of blood (one unit or 350 mL) within 90 days prior to study check-in in exclusion criteria and so on.......
I saw most of the criteria in all BE studies are nearly same.
Is it have any guideline or literature can explain them?

Many thanks advance!!!!

Complete thread:

BE study inclusion & exclusion criteriacher0424 2014-12-16 01:30 [Design Issues]
- 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 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