BE study inclusion & exclusion criteria [Design Issues]

posted by cher0424 – China, 2014-12-17 03:02 (4212 d 16:09 ago) – Posting: # 14089
Views: 16,400

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:

UA Flag
Activity
 Admin contact
23,656 posts in 4,994 threads, 1,570 registered users;
289 visitors (0 registered, 289 guests [including 20 identified bots]).
Forum time: 20:11 CEST (Europe/Vienna)

Most scientists today are devoid of ideas, full of fear, intent on
producing some paltry result so that they can add to the flood
of inane papers that now constitutes “scientific progress”
in many areas.    Paul Feyerabend

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5