Log in
Registerpilot/pivotal [Regulatives / Guidelines]
Dear MR Helmut,
Suppose if we conduct a Pilot Bioequivalence study with no. of subject as 12, and if the Biostudy passes the acceptance criteria; can we submitt the same data to the regulatory authorities, instead of going for a pivotal study. (for eg MCC SA min req of sub. is 12 only). Could u please throw some light on this.
With regards,
D.Ahmed
Suppose if we conduct a Pilot Bioequivalence study with no. of subject as 12, and if the Biostudy passes the acceptance criteria; can we submitt the same data to the regulatory authorities, instead of going for a pivotal study. (for eg MCC SA min req of sub. is 12 only). Could u please throw some light on this.
With regards,
D.Ahmed
Complete thread:
- pilot/pivotal ssk 2006-08-14 09:27
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- pilot/pivotal Helmut 2006-08-14 09:45
- pilot/pivotalAhmed meeran 2006-08-16 12:02
- BE demonstrated in pilot study Helmut 2006-08-16 12:44
- pilot/pivotal Essar 2006-11-17 05:48
- pilot/pivotal Helmut 2006-11-17 12:19
- pilot/pivotalAhmed meeran 2006-08-16 12:02
- pilot/pivotal Helmut 2006-08-14 09:45
Ing. Helmut Schütz