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Dear all,
I am looking for a formulae (the easiest) to calcule the sample size in
Bioequivalence study. This calculation must be in the protocol for all
bioequivalence study.
Best regards.
Annabelle
See: J. Pharmacokin. Biopharm. 20, No 5 1992: "Sample sizeBack to the Top
determination for
Bioequivalence Assessment using a Multiplicative Model" of Hauschke and
Steinijans.
That is in case you log-transform your data before analysis (which is
best
practice).
Kind regards,
Mrs. B. Snoeijer
Biometric Support
Leiden, Netherlands
Dear Annabelle,Back to the Top
As a ClinPharm Statistician I routinely use "nQuery Advisor" for my
sample
size calculations. Alternatively you can use the sample size analyst
within
the "SAS" software.
The formulae or calculations does not have to be in the Protocol
however the
sample size section should contain enough information that it could be
reproduced by Agencies (FDA/EU) if need be. FYI, "nQuery" can give you
a
sample paragraph containing your information which you could tweak for
your
Protocol (I use my own standard wording instead).
Regards.
Rob
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