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RegisterSubmitting a pilot as a pivotal study [Study Assessment]
Dear Lechia,
I do agree with Dr Dan. To submit data of pilot BE study (as a pivotal study), all you need to consider is - test product must be from exhibit batch (submission batch). Secondly, BE study should be conducted on at least 14 subjects (preferably N: 16). This would be possible for drugs with low within subject variability. If pilot BE study data are comfortable, same can be submitted. In my opinion, if you are mentioning all criteria as that of pivotal BE study protocol except small number of subjects, in effect that will not be considered as a cheating.
Regards,
Samaya.
I do agree with Dr Dan. To submit data of pilot BE study (as a pivotal study), all you need to consider is - test product must be from exhibit batch (submission batch). Secondly, BE study should be conducted on at least 14 subjects (preferably N: 16). This would be possible for drugs with low within subject variability. If pilot BE study data are comfortable, same can be submitted. In my opinion, if you are mentioning all criteria as that of pivotal BE study protocol except small number of subjects, in effect that will not be considered as a cheating.
Regards,
Samaya.
Complete thread:
- Submitting a pilot as a pivotal study lechia 2015-04-06 16:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Submitting a pilot as a pivotal study Helmut 2015-04-06 19:24
- Submitting a pilot as a pivotal study ElMaestro 2015-04-06 19:46
- pilot ≠ pivotal study Dr_Dan 2015-04-07 11:43
- Submitting a pilot as a pivotal studySamaya B 2015-04-07 12:44
- Submitting a pilot as a pivotal study lechia 2015-04-09 18:01
- Submitting a pilot as a pivotal study Helmut 2015-04-06 19:24
Ing. Helmut Schütz