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How about a parallel design study?
does anybody know if amiodarone has a high intra-subject variability
in clearance and distribution?
Thanks.
Sherwin
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The following message was posted to: PharmPK
Dear Sherwin!
Search the archive; you may find
http://www.boomer.org/pkin/PK03/PK2003021.html
> How about a parallel design study?
>
> does anybody know if amiodarone has a high intra-subject variability
> in clearance and distribution?
OK, we found CVintra of 30.4% for AUC0-72h and 29.6% for Cmax.
best regards,
Helmut
Ing. Helmut SchA\0x00tz
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
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Sherwin, re Amiodarone,
Yes, the oral form of Amiodarone has a high intra-subject variability:
American Family Physician Dec. 1, 2003.: The bioavailability of
amiodarone is variable but generally poor, ranging from 22 to 95
percent. Absorption is enhanced when the drug is taken with food..
Amiodarone is a presumptably a hydrotrope, and may aggregrate with
fats and bile acids.
Frank Bales, Ph.D.
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Amiodarone is a drug with a high within-subject variability,
especially regarding Cmax.
Our obseravtions on Amiodarone relative BA support the point that
"because of its high variability across individuals switching between
different Amiodarone formulations should not be encouraged".
For more details on Amiodarone BE study see:
Atanasova, I. and D. Terziivanov. Evaluation of average
bioequivalence of two oral formulations of amiodarone hydrochloride
after single administartion to healthy volunteers. Clin Drug Invest
2001;21(6):423-428.
The article might be of help to you.
Regards,
Dimiter Terziivanov
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