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balakotu ★ India, 2014-05-19 16:06 (4009 d 16:30 ago) Posting: # 12970 Views: 4,805 |
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Dear All, Please clarify the below query We conducted fed pivotal BE study. The clinical phase of study is initiated with 36 subjects as per protocol, out of 36 subjects only 17 Subjects completed the analysis. Whether we can submit the BE data with this less number of subjects (N=17 Subjects). Please share your thoughts on regulatory concerns in such cases of high dropouts. Regards Kotu. Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2014-05-19 16:23 (4009 d 16:14 ago) @ balakotu Posting: # 12971 Views: 4,046 |
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Dear Kotu, I don’t think that there will a problem if you were able to demonstrate BE in just 17 subjects. BTW, which was the cause of a drop out-rate of almost 50%? Was the T/R-ratio better and/or the CV lower than expected? — 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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nobody nothing 2014-05-19 16:28 (4009 d 16:08 ago) @ Helmut Posting: # 12972 Views: 4,013 |
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50% fall-out? I would buy some tickets and have a visit at that site, as a sponsor as well as a regulator... — Kindest regards, nobody |
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jag009 ★★★ NJ, 2014-05-19 17:58 (4009 d 14:38 ago) @ balakotu Posting: # 12973 Views: 3,987 |
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Hi, FDA? Not a problem if you demonstrate BE with 17 subjects. John |
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nobody nothing 2014-05-19 21:40 (4009 d 10:56 ago) @ jag009 Posting: # 12974 Views: 4,016 |
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Recently read an interesting article on the main reasons triggering FDA audits at clinical sites for BE trials  — Kindest regards, nobody |
Ing. Helmut Schütz