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The following message was posted to: PharmPK
Hi,
can anyone let me know if the molecule/drug - Fenofibrate falls under
the
category of a Highly Variable Drug.
If yes, then what is the approx. reported value of the intrasubject
variability ?
Madhuri
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Hi Madhuri,
I dont think that Fenofibrate falls under highly variable drugs
category. You can estimate the intra-subject variability from the
previously conducted BA/BE studies.
Ref Article: Bioequivalence of fenofibrate tablet formulations in
health Indian male subjects
Rani S, Nivsarkar M, Rathod R, Guttikar S, Padh H
http://www.ijpsonline.com
--
Regards,
Vaibhav M. Kerkar
Statistical Analyst
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The following message was posted to: PharmPK
In the following reference, the Cmax and AUC values of active
fenofibric acid had CV% of < 30% (Table I):
J Clin Pharmacol. 2000 Mar;40(3):316-23.
Lack of a clinically significant pharmacokinetic interaction between
fenofibrate and pravastatin in healthy volunteers.
Pan WJ, Gustavson LE, Achari R, Rieser MJ, Ye X, Gutterman C, Wallin BA.
Department of Clinical Pharmacokinetics and Toxicokinetics, Abbott
Laboratories, Abbott Park, Illinois 60064-6104, USA.
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