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Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects.
Bioanalysis 2018; 10(4):241-255B

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.

Authors+Show Affiliations

Bioanalysis, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.CRO RA CMC 4, R&D Chief Regulatory Office, GlaxoSmithKline Pharmaceuticals, 1250 S. Collegeville Rd, Collegeville, PA 19426, USA.Bioanalysis, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.Bioanalysis, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.Exploratory Biomarker Assay, In-vitro/In-vivo Translation, Platform Technology & Science, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA.

Pub Type(s)

Evaluation Studies
Journal Article

Language

eng

PubMed ID

29333871

Citation

Fang, Kasie, et al. "Drug Monitoring By Volumetric Absorptive Microsampling: Method Development Considerations to Mitigate Hematocrit Effects." Bioanalysis, vol. 10, no. 4, 2018, pp. 241-255.
Fang K, Bowen CL, Kellie JF, et al. Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects. Bioanalysis. 2018;10(4):241-255.
Fang, K., Bowen, C. L., Kellie, J. F., Karlinsey, M. Z., & Evans, C. A. (2018). Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects. Bioanalysis, 10(4), pp. 241-255. doi:10.4155/bio-2017-0221.
Fang K, et al. Drug Monitoring By Volumetric Absorptive Microsampling: Method Development Considerations to Mitigate Hematocrit Effects. Bioanalysis. 2018;10(4):241-255. PubMed PMID: 29333871.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects. AU - Fang,Kasie, AU - Bowen,Chester L, AU - Kellie,John F, AU - Karlinsey,Molly Z, AU - Evans,Christopher A, Y1 - 2018/01/15/ PY - 2018/1/16/pubmed PY - 2018/8/3/medline PY - 2018/1/16/entrez KW - LC–MS/MS KW - dried blood spot (DBS) KW - hematocrit (HCT) KW - matrix effect KW - microsampling KW - pharmacokinetics (PK) KW - regulated bioanalysis KW - toxicokinetics (TK) KW - volumetric absorptive microsampling (VAMS) device SP - 241 EP - 255 JF - Bioanalysis JO - Bioanalysis VL - 10 IS - 4 N2 - 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. SN - 1757-6199 UR - https://www.unboundmedicine.com/medline/citation/29333871/Drug_monitoring_by_volumetric_absorptive_microsampling:_method_development_considerations_to_mitigate_hematocrit_effects_ L2 - https://www.future-science.com/doi/full/10.4155/bio-2017-0221?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -