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RegisterInclusion of Smokers [Design Issues]
Hello guys and girls,
No issues (unless FDA specified/metabolite pathway issues). We submitted studies with smokers+non-smokers. I prefer non-smokers though but never did a study with only smokers (okay, except for a NDA study which we did for a smoking sessation drug).
John
❝ ❝ What's US FDA current standing on inclusion of smokers in a BE Study?
❝
❝ Interesting question!
No issues (unless FDA specified/metabolite pathway issues). We submitted studies with smokers+non-smokers. I prefer non-smokers though but never did a study with only smokers (okay, except for a NDA study which we did for a smoking sessation drug).
John
Complete thread:
- Inclusion of Smokers IID 2014-04-11 15:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Inclusion of Smokers Helmut 2014-04-11 16:37
- Inclusion of Smokersjag009 2014-04-11 17:57
- Inclusion of Smokers IID 2014-04-12 04:34
- Inclusion of Smokers IID 2014-04-12 04:36
- Inclusion of Smokersjag009 2014-04-11 17:57
- Subgroup analysis? Helmut 2014-04-12 15:28
- Inclusion of Smokers Helmut 2014-04-11 16:37
Ing. Helmut Schütz