NDLI: Population pharmacokinetic analysis of clopidogrel in healthy Jordanian subjects with emphasis optimal sampling strategy.

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Species differences of organic anion transporters involved in the renal uptake of 4-amino-3-chlorophenyl hydrogen sulfate, a metabolite of resatorvid, between rats and dogs.

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Population pharmacokinetic analysis of clopidogrel in healthy Jordanian subjects with emphasis optimal sampling strategy.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Yousef, A. M. Melhem, M. Xue, B. Arafat, T. Reynolds, D. K. Van Wart, S. A.
Spatial Coverage	Jordan
Description	Country affiliation: Jordan Author Affiliation: Yousef AM ( Department of Biopharmaceutics and Clinical Pharmacy, University of Jordan, Amman, Jordan.)
Abstract	AIM: Clopidogrel is metabolized primarily into an inactive carboxyl metabolite (clopidogrel-IM) or to a lesser extent an active thiol metabolite. A population pharmacokinetic (PK) model was developed using NONMEM(®) to describe the time course of clopidogrel-IM in plasma and to design a sparse-sampling strategy to predict clopidogrel-IM exposures for use in characterizing anti-platelet activity. METHODS: Serial blood samples from 76 healthy Jordanian subjects administered a single 75 mg oral dose of clopidogrel were collected and assayed for clopidogrel-IM using reverse phase high performance liquid chromatography. A two-compartment (2-CMT) PK model with first-order absorption and elimination plus an absorption lag-time was evaluated, as well as a variation of this model designed to mimic enterohepatic recycling (EHC). Optimal PK sampling strategies (OSS) were determined using WinPOPT based upon collection of 3-12 post-dose samples. RESULTS: A two-compartment model with EHC provided the best fit and reduced bias in C(max) (median prediction error (PE%) of 9.58% versus 12.2%) relative to the basic two-compartment model, AUC(0-24) was similar for both models (median PE% = 1.39%). The OSS for fitting the two-compartment model with EHC required the collection of seven samples (0.25, 1, 2, 4, 5, 6 and 12 h). Reasonably unbiased and precise exposures were obtained when re-fitting this model to a reduced dataset considering only these sampling times. CONCLUSIONS: A two-compartment model considering EHC best characterized the time course of clopidogrel-IM in plasma. Use of the suggested OSS will allow for the collection of fewer PK samples when assessing clopidogrel-IM exposures.
File Format	HTM / HTML
ISSN	01422782
Issue Number	4
Volume Number	34
e-ISSN	1099081X
Journal	Biopharmaceutics & Drug Disposition
Language	English
Publisher	Wiley
Publisher Date	2013-05-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Pharmacology Models, Biological Platelet Aggregation Inhibitors Pharmacokinetics Ticlopidine Analogs & Derivatives Administration, Oral Adolescent Adult Area Under Curve Chromatography, High Pressure Liquid Chromatography, Reverse-phase Humans Jordan Male Middle Aged Time Factors Young Adult Clinical Trial Comparative Study Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Pharmacology Pharmacology (medical) Pharmaceutical Science

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