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RegisterCompiling data [Study Performance]
Dear all,
we conducted a BE study and due to the difficiency of subjects and time we had to do the same BE twice (same study on two separate occasions/different dates).
OK we had in the first group around 24 subjects and in the second 5 subjects to compliment the samples size of 28. Reasons we did this, some regions where the registration takes place, the regulatory bodies insist to have the exact sample size discussed in the protocol.
the question is, can we combine the data since we maintained the same control measures described in the protocol? In case we face trouble what tests can be made statistically to argue that its still ok to do so. the guidlines are not specific to this issue.
Your advice and help are greatly appreciated and I hope we're not in trouble.
Thanks
Raja Sammour
we conducted a BE study and due to the difficiency of subjects and time we had to do the same BE twice (same study on two separate occasions/different dates).
OK we had in the first group around 24 subjects and in the second 5 subjects to compliment the samples size of 28. Reasons we did this, some regions where the registration takes place, the regulatory bodies insist to have the exact sample size discussed in the protocol.
the question is, can we combine the data since we maintained the same control measures described in the protocol? In case we face trouble what tests can be made statistically to argue that its still ok to do so. the guidlines are not specific to this issue.
Your advice and help are greatly appreciated and I hope we're not in trouble.
Thanks
Raja Sammour
Complete thread:
- Compiling datarajasammour 2007-09-21 06:44
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Compiling data Charl 2007-09-24 09:36
- Compiling data rajasammour 2007-09-25 06:54
- Compiling data Charl 2007-09-24 09:36
Ing. Helmut Schütz