AMS method validation for quantitation in pharmacokinetic studies with concomitant extravascular and intravenous administration

Lappin, Graham and Seymour, Mark and Young, Graeme and Higton, David and Hill, Howard M. (2011) AMS method validation for quantitation in pharmacokinetic studies with concomitant extravascular and intravenous administration. Bioanalysis, 3 (4). pp. 393-405. ISSN 1757-6180

Full content URL: http://dx.doi.org/10.4155/bio.11.5

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Item Type:Article
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Abstract

A technique has emerged in the past few years that has enabled a drug's intravenous pharmacokinetics to be readily obtained in humans without having to conduct extensive toxicology studies by this route of administration or expend protracted effort in formulation. The technique involves the intravenous administration of a low dose of 14C-labelled drug (termed a tracer dose) concomitantly with a non-labelled extravascular dose given at therapeutically levels. Ces collected over time are analysed to determine the total parent drug concentration by LC-MS (which essentially measures that arising from the oral dose) and by LC followed by accelerator mass spectrometry (AMS) to determine the 14C-drug concentration (i.e., that arising from the intravenous dose). There are currently no published accounts of how the principles of bioanalytical validation might be applied to intravenous studies using AMS as an analytical technique. The authors describe the primary elements of AMS when used with LC seperation and how this off-line technique differs from LC-MS. They then discuss how the principles of bioanalytical validation might be applied to determine selectivity, accuracy, precision and stability of methods involving LC followed by AMS analysis. © 2011 Future Science Ltd.

Keywords:carbon 14, drug, accelerator mass spectrometry, accuracy, calibration, chromatography, drug administration route, drug efficacy, drug formulation, drug microdose, drug safety, drug screening, high performance liquid chromatography, human, ion current, isotope dilution assay, liquid chromatography, liquid scintillation counting, mass spectrometry, quantitative analysis, review, ultra performance liquid chromatography, Drug Administration Routes, Government Regulation, Humans, Pharmaceutical Preparations, Pharmacokinetics, Veins
Divisions:College of Science > School of Pharmacy
ID Code:8211
Deposited On:24 Mar 2013 11:45

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