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RegisterPilot study data submission as pivotal study [Off Topic]
Dear forum members,
If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects?
Interesting to know the opinions.
Thank you.
Regards,
QA
If pilot study passes the bio-equivalence criteria with 12 evaluable subjects, can it be submitted to the regulatory authority instead of conducting another pivotal study based on ethical reason and to avoid any unnecessary exposure of drug to healthy human subjects?
Interesting to know the opinions.
Thank you.
Regards,
QA
Complete thread:
- Pilot study data submission as pivotal studyqualityassurance 2023-10-02 12:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pilot study data submission as pivotal study dshah 2023-10-03 16:30
Ing. Helmut Schütz