Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects-Reference-Cited by-同舟云学术

Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects

Published:2018-02 Issue:4 Volume:10 Page:241-255
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Fang Kasie¹,Bowen Chester L²,Kellie John F¹,Karlinsey Molly Z¹,Evans Christopher A³

Affiliation:

1. Bioanalysis, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA

2. CRO RA CMC 4, R&D Chief Regulatory Office, GlaxoSmithKline Pharmaceuticals, 1250 S. Collegeville Rd, Collegeville, PA 19426, USA

3. Exploratory Biomarker Assay, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA

Abstract

Aim: GSKA is a compound that was in development in clinical trials. A bioanalysis method to quantify GSKA using volumetric absorptive microsampling (VAMS) was developed and hematocrit (HCT) related assay bias was investigated. Methodology: After accurate sampling of 10 μl blood, VAMS tips were air dried approximately 18 h and desorbed by an aqueous solution containing internal standard. The recovered blood underwent liquid–liquid extraction in ethyl acetate to minimize matrix suppression. Assay accuracy, precision, linearity, carryover, selectivity, recovery, matrix effects, HCT effects and long-term quality control stability were evaluated. Conclusion: HCT-related assay bias was minimized in 30–60% blood HCT range, and all validation parameters met acceptance criteria. The method is suitable for quantitative analysis of GSKA in human blood.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio-2017-0221

Reference31 articles.

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