Back to the Top
Dear friends,
We would like to do bioequivalence study of Bicalutamide tablets which
has a half life of about 120 hours.can we go for a parallel study with
truncation(AUC0-120)?or is it mandatory to go for a two way crossover
study with sampling for 672 hours with a washout period of 7 weeks?
thanks and regards,
Muhiyideen
Back to the Top
The following message was posted to: PharmPK
Dear Muhiyideen
For long half life drugs you can move along with a truncated study. You
can refer to ICH guidelines for bioequivalence of long half life drugs.
So for the regulatory it is always acceptable if you submit data of
truncated study.
Regards
Anita
Back to the Top
The following message was posted to: PharmPK
Dear Anita!
you wrote:
> You
> can refer to ICH guidelines for bioequivalence of long half life
drugs.
> So for the regulatory it is always acceptable if you submit data of
> truncated study.
>
An ICH guideline for bioequivalence does not exist - and is not even
under consideration within the three ICH regions.
Maybe Sections 6.2.2 and 6.6.2 of WHO's guideline (May 2006) are
helpful:
http://mednet3.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex7_eng.pdf
For other national guidelines see:
http://bebac.at/Guidelines.htm
Best regards,
Helmut
--
Ing. Helmut Schutz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna, Austria
e-mail helmut.schuetz.-a-.bebac.at
web http://bebac.at
forum http://forum.bebac.at
Back to the Top
The following message was posted to: PharmPK
Dear Mohammed!
A cross-over design has a lot of drawbacks: study duration, 7 weeks
of washout may not be enough for some subjects, dropouts,...
I would suggest to go with a parallel study; the time point of
truncation
is dictated by the maximum residence time of the compound in the GIT
tract
- or to be more precise, within the absorption window.
120 hours are pretty long; generally 72 - 96 hours should do the job.
Since bicalutamide is subjected to polymorphism, screeening and
inclusion
of fast metabolizers (urinary metabolization ratio of metoprolol /
alpha-hydroxy-metoprolol <=12.6) only is suggested.
In some regulations you will have to go with enantiomeric separation;
R(-) bicalutamide as the primary (confirmatory) parameter, and S(+)
as secondary (exploratory only).
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
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 "BE study of Bicalutamide" as the subject | Support PharmPK by using the |
Copyright 1995-2011 David W. A. Bourne (david@boomer.org)