Bioequivalence and Bioavailability Forum

rajasammour
☆

2007-09-21 08:44
(6055 d 04:55 ago)

Posting: # 1105
Views: 4,529

Compiling 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. :-D

Thanks
Raja Sammour

Charl
●

2007-09-24 11:36
(6052 d 02:04 ago)

@ rajasammour
Posting: # 1119
Views: 3,478

Compiling data

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Dear Raja...

what is the time interval that separated the study and its conjugate?

My opinion is that your not in a big trouble, thus you need to do re-evaluation for all 28 subjects again together.

notes:

did all subjects experienced the same conditions through the clinical phase?
you should prove this.
did you study the stability of the drug for the entire period ( 1st clinical trial + the 2nd)?

regards
Charl

rajasammour
☆

2007-09-25 08:54
(6051 d 04:46 ago)

@ Charl
Posting: # 1125
Views: 3,473

Compiling data

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Dear Charl,

thanks for your reply. The complimentary study phase I started off at phase II of the original/primary study. the washout is 3 wks so the 2nd phase of the complimentary was 3 wks away from the 2nd phase of the original study.
We did the same protocol controls so the study is basically the same except for the issue of dates.

Proving conditions would probably require submission of source documents copies in the BE file from both studies and i cant think any other way.
We do the stability tests right from when we did first dosing so we are kind of covered on this issue.

Well, we are planning to do test for equivalence on the first part where the bulk of the sample size is and then add up the whole lot (28) and test it as a whole study and compare results hoping it pass well in both cases with good power. I hope this is an acceptable approach.

thank you again so much
kind regards

Compiling data [Study Per­for­mance]

Compiling data

Compiling data

Compiling data [Study Performance]