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mmw ☆ India, 2015-04-25 15:33 (3282 d 11:29 ago) Posting: # 14736 Views: 5,016 |
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Dear All, According to the EMA GL CPMP/EWP/QWP/1401/98 Rev. 1/ Corr**London, 20 January 2010, "Subjects should preferably be non-smokers" However, I have referred BE studies of Nicotine Replacements Therapy (NRT) Products (Gum, lozenges, microtab, mints etc) and noticed that only healthy-smokers had been used in NRT products BE studies. My queries are:
Thanks and regards, MMW |
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Helmut ★★★   Vienna, Austria, 2015-04-25 17:03 (3282 d 09:59 ago) @ mmw Posting: # 14737 Views: 4,085 |
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Hi mmw, ❝ According to the EMA GL[…] "Subjects should preferably be non-smokers" Should preferrably be does not mean have to be, must be, etc. ❝ I have referred BE studies of Nicotine Replacements Therapy (NRT) […] and noticed that only healthy-smokers had been used in NRT products BE studies. Yep. In all studies I have seen as well. ❝ 1. What is the rationale behind the selection of healthy smokers for BE studies of NRT products? ? Smokers are addicted to nicotine and adapted to the effects/AEs. You don’t want to have a lot its AEs caused in non-smokers. ❝ 2. Can we use healthy non-smokers for BE study of NRT products? Can we follow the GL only? I wouldn’t. The GL is not a law. ❝ 3. Is there any regulatory compulsion for use of healthy smokers in BE study of NRT products? Specially EU. Not that I recall. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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mmw ☆ India, 2015-04-27 08:22 (3280 d 18:40 ago) @ Helmut Posting: # 14738 Views: 3,935 |
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Dear Sir, Thanks for your reply. Thanks MMW |
Ing. Helmut Schütz