Review Ho & Gao
zotarolimus concentration determination in stented swine arteries by liquid chromatography/tandem mass spectrometry detection. Rapid Commun. Mass Spectrom. 20(22), 3427–3434 (2006).
23 Niklowitz P, Doering F, Paulussen M, Menke T. Determination of coenzyme Q10 tissue status via high- performance liquid chromatography with electrochemical detection in swine tissues (Sus scrofa domestica). Anal. Biochem. 437(1), 88–94 (2013).
24 Noll BD, Coller JK, Somogyi AA et al. Measurement of cyclosporine A in rat tissues and human kidney transplant biopsies – a method suitable for small (<1 mg) samples. Ther. Drug Monit. 33, 688–693 (2011).
25 Noll BD, Coller JK, Somogyi AA et al. Validation of an LC–MS/MS method to measure tacrolimus in rat kidney and liver tissue and its application to human kidney biopsies. Ther. Drug Monit. 35(5), 617–623 (2013).
26 Mcnamara KM, Harwood DT, Simanainen U, Walters KA, Jimenez M, Handelsman DJ. Measurement of sex steroids in murine blood and reproductive tissues by liquid chromatography-tandem mass spectrometry. J. Steroid Biochem. Mol. Biol. 121(3–5), 611–618 (2010).
27 Teunissen SF, Vlaming MLH, Rosing H, Schellens JHM, Schinkel AH, Beijnen JH. Development and validation of a liquid chromatography-tandem mass spectrometry assay for the analysis of 2-amino-1-methyl-6-phenylimidazo[4,5-b] pyridine (PhIP) and its metabolite 2-hydroxyamino-1- methyl-6-phenylimidazo[4,5-b]pyridine (N-OH-PhIP) in plasma, urine, bile, intestinal contents, faeces and 8 selected tissues from mice. J. Chromatogr. B 878(25), 2353–2362 (2010).
• Good example for surrogate matrix validation, particularly regarding stability assessment.
28 Korecka M, Clark CM, Lee VMY, Trojanowski JQ, Shaw LM. Simultaneous HPLC–MS–MS quantification of 8-iso- PGF2α and 8,12-iso-iPF2α in CSF and brain tissue samples with on-line cleanup. J. Chromatogr. B 878(24), 2209–2216 (2010).
29 Smith D, Smith L, Shafer W, Klotz J, Strickland J. Development and validation of an LC–MS method for quantitation of Ergot alkaloids in lateral saphenous vein tissue. J. Agric. Food Chem. 57, 7213–7220 (2009).
30 Wang G, Korfmacher WA. Development of a biomarker assay for 3-indoxyl sulfate in mouse plasma and brain by liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 23(13), 2061–2069 (2009).
31 Zacs D, Rjabova J, Pugajeva I, Nakurte I, Viksna A, Bartkevics V. Ultra high performance liquid chromatography–time-of-flight high resolution mass spectrometry in the analysis of hexabromocyclododecane diastereomers: method development and comparative evaluation versus ultra high performance liquid chromatography coupled to Orbitrap high resolution mass spectrometry and triple quadrupole tandem mass spectrometry. J. Chromatogr. A 1366(0), 73–83 (2014).
32 Zacs D, Rjabova J, Bartkevics V. New perspectives on diastereoselective determination of hexabromocyclododecane traces in fish by ultra high performance liquid
chromatography-high resolution orbitrap mass spectrometry. J. Chromatogr. A 1330, 30–39 (2014).
33 Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin. Pharmacol. Ther. 69(3), 89–95 (2001).
34 Lee J, Devanarayan V, Barrett Y et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23(2), 312–328 (2006).
35 Lowes S, Hucker R, Jemal M et al. Tiered approaches to chromatographic bioanalytical method performance evaluation: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J. 17(1), 17–23 (2015).
36 Cummings J, Raynaud F, Jones L, Sugar R, Dive C. Fit-for- purpose biomarker method validation for application in clinical trials of anticancer drugs. Br. J. Cancer 103(9), 1313–1317 (2010).
37 Hucker R, Watson C, James I, Vincent S, Muirhead D. Measuring soluble biomarkers in clinical trials: do tiered approaches to the analysis and validation of assays provide an answer to the fit-for-purpose challenge? Bioanalysis 6(5), 605–609 (2014).
38 Xue YJ, Gao H, Ji QC et al. Bioanalysis of drug in tissue: current status and challenges. Bioanalysis 4(21), 2637–2653 (2012).
39 Timmerman P, Mokrzycki N, Delrat P et al. Recommendations from the European Bioanalysis Forum on method establishment for tissue homogenates. Bioanalysis 6(12), 1647–1656 (2014).
40 US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM): Guidance for Industry: Bioanalytical Method Validation. (2001).
www.fda.gov
•• Current guidance for plasma sample bioanalysis under regulatory setting in the USA. Most researchers adapt tissue method validation/qualification based on this document.
41 European Medicines Agency: Guideline on Bioanalytical Method Validation. EMEA/CHMP/EWP/192217/2009.
www.ema.europa.eu
42 US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM): Draft Guidance for Industry: Bioanalytical Method Validation (Revised).
www.fda.gov
43 Booth B, Arnold ME, De Silva B et al. Workshop Report: Crystal City V-Quantitative Bioanalytical Method Validation and Implementation: The 2013 Revised FDA Guidance. AAPS J. 17(2), 277–288 (2015).
44 Harmonised Tripartite ICH Guideline: Validation of Analytical Procedures: Methodology. Q2B.
www.fda.gov
45 Harmonised Tripartite ICH Guideline: Validation of Analytical Procedures: Text and Methodology. Q2(R1) (2006).
www.ich.org
•• The tripartite harmonised ICH Guideline on Text (previously coded Q2A) was finalized under Step 4 in
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