Back to the Top
I would like to know if the sample size presented Table 1 page 559 in
"Sample size determination for bioequivalence assessment using a
multiplicative model" HAUSCHKE D. ; STEINIJANS V. W. ; DILETTI E. ;
BURKE M. ;
Journal of pharmacokinetics and biopharmaceutics 1992, vol. 20, no5,
pp. 557-561 are in the case of a cross over study the number of
subjects for the study or for one group: for example if the table is
indicating 24 (power 80%, CV 22.5 and 0.95) does it means that it is
a cross over study with 12 subjects per group ( A - B and then B - A)
or does it means that it is 24 subjects per group and so 48 animals in
the study.
Thank you for your help
Kind Regards
Back to the Top
The following message was posted to: PharmPK
Dear Vincent!
> I would like to know if the sample size presented Table 1 page 559
in
> "Sample size determination for bioequivalence assessment using a
> multiplicative model" HAUSCHKE D. ; STEINIJANS V. W. ; DILETTI E. ;
> BURKE M. ;
> Journal of pharmacokinetics and biopharmaceutics 1992, vol. 20,
no5,
> pp. 557-561 are in the case of a cross over study the number of
> subjects for the study or for one group: for example if the table is
> indicating 24 (power 80%, CV 22.5 and 0.95) does it means that it is
> a cross over study with 12 subjects per group ( A - B and then B -
A)
> or does it means that it is 24 subjects per group and so 48 animals
in
> the study.
Quoting from the article (p 560, second paragraph)...
The total number of subjects [...] is N=2n (n denotes the number
of subjects per sequence) [...]
.... and third paragraph:
Table I gives the total sample sizes [...]
Therefore in your example n1=n2=12 and N=24. It's better to use
the term 'sequence' instead of 'group' in order to avoid con-
fusion: sometimes a study is performed in two parts; FDA uses
the term 'group' there.
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
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Sample Size for Bioequivalence Assessment" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)