Bioequivalence and Bioavailability Forum • BE study inclusion & exclusion criteria

BE study inclusion & exclusion criteria [Design Issues]

posted by cher0424 – China, 2014-12-17 03:02 (4203 d 19:53 ago) – Posting: # 14089
Views: 16,332

Dear Hulmet

❝ Well, cough… An influence of the smoking-status is only expected if the drug is metabolized by CYP450 1A1. Even then: If a subject doesn’t decide to quit smoking in the washout between study periods, what’s the problem?

So you mean smoking influence to drugs actually is case by case? Well, I had no idea about subjet smoking during wash-out, coz smoking status depends on their chief complaint

❝ ❝ and why donation of blood (one unit or 350 mL) within 90 days prior to study check-in in exclusion criteria

❝

❝ Tradition?

❝

❝ ❝ I saw most of the criteria in all BE studies are nearly same.

❝

❝ Copy & paste?

Maybe are, the protocol prepare in same CRO.

❝ The rationale behind most of these criteria is to ensure that subjects are healthy indeed. It is common misconception that tightening the limits (f.i. of the BMI) might reduce the variability and therefore, increase the chances to pass BE. In a crossover-study between-subject differences are irrelevant.

Speaking about BMI, if the value is 18, and some guideline said <18 is unhealthy, so 18 can be include or not?

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 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 criteriacher0424 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