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Dear all,
We have done a 4 way cross over replicate BE study for one of the
molecule, below is the output of the study and my question.
The output (WinNonlin) for Ln (Cmax) of a Replicate four way crossover
design with TRTR, RTRT sequences is as follows:
lambda(1,1)_11 0.160701
lambda(1,2)_11 0.158262
lambda(2,2)_11 0.000000
Var(Period*Treatment*Subject)_21 0.149078
Var(Period*Treatment*Subject)_22 0.107301
Now my question is:
How we can find out the Switchability, Prescribability and Global
Variance from the above data (how to interpret the data from the above
out put).
If any one has references or formulas, please share.
Thanks & Regards
RajaReddy Kallem
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The following message was posted to: PharmPK
Dear Raja,
just push the right button... ;-)
http://forum.bebac.at/mix_entry.php?id=2843#p2991
Best regards,
Helmut
- Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.-at-.bebac.at
web http://bebac.at/
contact http://bebac.at/Contact.htm
forum http://forum.bebac.at
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Raj:
You asked about switchability of dosage forms in a replicate cross-
over study. In WinNonlin Bioequivalence output you have to look for
subject-by-formulation interaction, if the p value is greater than
0.05 you can call your formulation switchable with RLD.
Hope this clarification will help.
Prasad Tata
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