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The following message was posted to: PharmPK
Dear all,
Can anybody help me to get the European guidelines for bioequivalence
studies involving males and females? Including the inclusion criteria
regard
the females body weight accepted and body mass index.
Thanks,
Rana
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The following message was posted to: PharmPK
Dear Rana,
you wrote:
> Can anybody help me to get the European guidelines for bioequivalence
> studies involving males and females? Including the inclusion criteria
> regard
> the females body weight accepted and body mass index.
>
See
http://www.emea.europa.eu/pdfs/human/ewp/140198en.pdf#page=7
Section 3.2.1 Selection of subjects:
'[...] Subjects could belong to either sex; however, the risk to women
of childbearing potential should be considered on an individual basis.
In general, subjects should be between 18 - 55 years old and of weight
within the normal range according to accepted normal values for the
Body Mass Index.'
In my experience a BMI range of 18-27kg/m^2 is most commonly applied,
irrespective of sex and age.
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
G'lines http://bebac.at/Guidelines.htm
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