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RegisterBE study inclusion & exclusion criteria [Design Issues]
posted by Helmut 
– Vienna, Austria, 2014-12-16 15:53 (4209 d 07:02 ago) – Posting: # 14085
Views: 16,463
Hi cher0424,
Define abuse.
EMA’s 2001 GL stated “Subjects should preferably be non-smokers […]. If moderate smokers are included (less than 10 cigarettes per day) they should be identified as such and the consequences for the study results should be discussed.” The second sentence was removed in the 2010 GL.
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?
Tradition?
Copy & paste?
Not that I recall. 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.
Parallel designs are another cup of tea. Keeping groups as similar as possible (even by genotyping) makes sense indeed.
❝ what's the exactly impart to study when subjet abuse smoking ?
Define abuse.
EMA’s 2001 GL stated “Subjects should preferably be non-smokers […]. If moderate smokers are included (less than 10 cigarettes per day) they should be identified as such and the consequences for the study results should be discussed.” The second sentence was removed in the 2010 GL.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?
❝ 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?
❝ Is it have any guideline or literature can explain them?
Not that I recall. 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.
Parallel designs are another cup of tea. Keeping groups as similar as possible (even by genotyping) makes sense indeed.
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- BE study inclusion & exclusion criteria cher0424 2014-12-16 01:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study inclusion & exclusion criteriaHelmut 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
- Drugs of abuse cher0424 2014-12-18 04:54
- Drugs of abuse Helmut 2014-12-17 14:42
- BE study inclusion & exclusion criteria Helmut 2014-12-17 13:33
- BE study inclusion & exclusion criteria cher0424 2014-12-17 02:19
- 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 2014-12-16 17:29
- BE study inclusion & exclusion criteria Ohlbe 2014-12-17 17:35
- BE study inclusion & exclusion criteriaHelmut 2014-12-16 14:53
Ing. Helmut Schütz