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If anyone have experience in calculating BE in a parallel study
design using WinNonlin, Please advise me how to perform this
analysis. If you can provide me your contact details I will call you
to go over the details.
Prasad NV Tata, Ph.D., FCP
675 McDonnell Blvd.
Saint Louis, MO 63134
[I routinely remove phone info from postings so you will need to
contact Prasad directly - db]
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[I have received multiple copies of two messages today and I've had
one member report this for at least one message as well. There seem to
be some network gremlins at work, at work. I've restart my server
which might help, hopefully, but it could be something outside my
control - db]
The following message was posted to: PharmPK
> If anyone have experience in calculating BE in a parallel study
> design using WinNonlin, Please advise me how to perform this
You need two columns in your Workbook (although you may
use a third one for subject in order to avoid confusion):
Formulation and Response (e.g. AUC, Cmax, whatsoever).
There's only one fixed effect in the model, namely formulation.
Fire up the Bioequivalence Wizard
Type of Study > Parallel
Choose your "reference" from the select box > Next
Drag your response variable to "Dependent Variables" box > Next
No changes in the next window > Next
Check the Confidence Level, Acceptance range > Calculate
Enjoy, BUT beware:
WinNonlin does not allow to calculate BE based on unequal
variances (mandatory as of FDA).
For details see this post:
Best regards & good look,
Ing. Helmut SchA\0x00tz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
1070 Vienna, Austria
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