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RegisterRegulatives Submission Issues [Study Assessment]
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]
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]
Complete thread:
- Regulatives Submission Issuesbalakotu 2014-05-19 14:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Regulatives Submission Issues Helmut 2014-05-19 14:23
- Regulatives Submission Issues nobody 2014-05-19 14:28
- Regulatives Submission Issues jag009 2014-05-19 15:58
- Regulatives Submission Issues nobody 2014-05-19 19:40
- Regulatives Submission Issues Helmut 2014-05-19 14:23
Ing. Helmut Schütz