Volumetric absorptive microsampling–LC–MS/MS assays for quantitation of giredestrant in dried human whole blood

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References

• 1. Simundic AM, Church S, Cornes MP et al. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: an observational study by the European Federation of Clinical and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE). Clin. Chem. Lab. Med. 53(9), 1321–1331 (2015).
  Medline CASGoogle Scholar
• 2. Davit CJ, Hundley RJ, Bacic JD, Hanson EM. A pilot study to improve venipuncture compliance in children and adolescents with autism spectrum disorders. J. Dev. Behav. Pediatr. 32(7), 521–525 (2011).
  MedlineGoogle Scholar
• 3. Trifonova OP, Maslov DL, Balashova EE, Lokhov PG. Evaluation of dried blood spot sampling for clinical metabolomics: effects of different papers and sample storage stability. Metabolites 9(11), 277 (2019).
  Medline CASGoogle Scholar
• 4. Tobin NH, Murphy A, Li F et al. Comparison of dried blood spot and plasma sampling for untargeted metabolomics. Metabolomics 17(7), 62 (2021).
  Medline CASGoogle Scholar
• 5. Van Dooijeweert B, Broeks MH, Verhoeven-Duif NM et al. Untargeted metabolic profiling in dried blood spots identifies disease fingerprint for pyruvate kinase deficiency. Haematologica 106(10), 2720–2725 (2021).
  Medline CASGoogle Scholar
• 6. Yuan Y, Xu Y, Lu J. Dried blood spots in doping analysis. Bioanalysis 13(7), 587–604 (2021).
  CASGoogle Scholar
• 7. Nijenhuis CM, Huitema ADR, Marchetti S et al. The use of dried blood spots for pharmacokinetic monitoring of vemurafenib treatment in melanoma patients. J. Clin. Pharmacol. 56(10), 1307–1312 (2016).
  Medline CASGoogle Scholar
• 8. Dilo A, Daali Y, Desmeules J, Chalandon Y, Uppugunduri CRS, Ansari M. Comparing dried blood spots and plasma concentrations for busulfan therapeutic drug monitoring in children. Ther. Drug Monit. 42(1), 111–117 (2020).
  Medline CASGoogle Scholar
• 9. Duthaler U, Berger B, Erb S et al. Using dried blood spots to facilitate therapeutic drug monitoring of antiretroviral drugs in resource-poor regions. J. Antimicrob. Chemother. 73(10), 2729–2737 (2018).
  Medline CASGoogle Scholar
• 10. De Kesel PMM, Capiau S, Lambert WE, Stove CP. Current strategies for coping with the hematocrit problem in dried blood spot analysis. Bioanalysis 6(14), 1871–1874 (2014).
  Google Scholar
• 11. Luo Y, Korfmacher W, Ho S et al. Evaluation of two blood microsampling approaches for drug discovery PK studies in rats. Bioanalysis 7(18), 2345–2359 (2015).
  CASGoogle Scholar
• 12. Li H, Bigwarfe T, Myzithras M, Waltz E, Ahlberg J. Application of Mitra microsampling for pharmacokinetic bioanalysis of monoclonal antibodies in rats. Bioanalysis 11(1), 13–20 (2019).
  CASGoogle Scholar
• 13. John H, Willoh S, Hormann P, Siegert M, Vondran A, Thiermann H. Procedures for analysis of dried plasma using microsampling devices to detect sulfur mustard–albumin adducts for verification of poisoning. Anal. Chem. 88(17), 8787–8794 (2016).
  Medline CASGoogle Scholar
• 14. Taylor JM, Hughes AT, Milan AM, Rudge J, Davison AS, Ranganath LR. Evaluation of the Mitra microsampling device for use with key urinary metabolites in patients with alkaptonuria. Bioanalysis 10(23), 1919–1932 (2018).
  CASGoogle Scholar
• 15. Nakadi FV, Garde R, da Veiga MAMS, Cruces J, Resano M. A simple and direct atomic absorption spectrometry method for the direct determination of Hg in dried blood spots and dried urine spots prepared using various microsampling devices. J. Anal. At. Spectrom. 35(1), 136–144 (2020).
  CASGoogle Scholar
• 16. Bloem K, Schaap T, Boshuizen R et al. Capillary blood microsampling to determine serum biopharmaceutical concentration: mitra microsampler vs dried blood spot. Bioanalysis 10(11), 815–823 (2018). • A comparison of device performance for Mitra volumetric adsorption microsampling (VAMS) and dried blood spot cards to identify whether the former is a suitable alternative.
  CASGoogle Scholar
• 17. Salamin O, Nicoli R, Xu C et al. Steroid profiling by UHPLC–MS/MS in dried blood spots collected from healthy women with and without testosterone gel administration. J. Pharm. Biomed. Anal. 204, 114280 (2021). • A comparison of steroid profiles generated from Tasso-M20 and finger-prick dried blood spots to establish correlation between samples collected from the upper arm and the finger.
  Medline CASGoogle Scholar
• 18. Solheim SA, Ringsted TK, Nordsborg NB, Dehnes Y, Levernaes MCS, Morkeberg J. No pain just gain: painless, easy, and fast dried blood spot collection from fingertip and upper arm in doping control. Drug Test. Anal. 13(10), 1783–1790 (2021).
  Medline CASGoogle Scholar
• 19. Heiland CE, Ericsson M, Pohanka A, Ekstrom L, Marchand A. Optimizing detection of erythropoietin receptor agonists from dried blood spots for anti-doping application. Drug Test. Anal. 14(8), 1377–1386 (2022).
  Medline CASGoogle Scholar
• 20. Miller GD, Husk J, Crouch AK, Eichner D. Growth hormone isoform testing in capillary dried blood spots: results from single and multiple dose administration studies and large-scale field collections. Drug Test. Anal. 14(7), 1255–1263 (2022).
  Medline CASGoogle Scholar
• 21. Andersen IKL, Rosting C, Gjelstad A, Halvorsen TG. Volumetric absorptive microsampling vs other blood sampling materials in LC–MS-based protein analysis – preliminary investigations. J. Pharm. Biomed. Anal. 156, 239–246 (2018).
  Medline CASGoogle Scholar
• 22. Liang J, Zbieg JR, Blake RA et al. GDC-9545 (Giredestrant): a potent and orally bioavailable selective estrogen receptor antagonist and degrader with an exceptional preclinical profile for ER plus breast cancer. J. Med. Chem. 64(16), 11841–11856 (2021).
  Medline CASGoogle Scholar
• 23. Jhaveri KL, Boni V, Sohn J et al. Safety and activity of single-agent giredestrant (GDC-9545) from a phase Ia/b study in patients (pts) with estrogen receptor-positive (ER+), HER2-negative locally advanced/metastatic breast cancer (LA/mBC). J. Clin. Oncol. 39(Suppl. 15), Abstract 1017 (2021).
  Google Scholar
• 24. US FDA. Bioanalytical Method Validation Guidance for Industry. (2018).
  Google Scholar
• 25. Kip AE, Kiers KC, Rosing H, Schellens JHM, Beijnen JH, Dorlo TPC. Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples. J. Pharm. Biomed. Anal. 135, 160–166 (2017).
  Medline CASGoogle Scholar
• 26. Undre N, Hussain I, Meijer J, Stanta J, Swan G, Dawson I. Quantitation of tacrolimus in human whole blood samples using the Mitra microsampling device. Ther. Drug Monit. 43(3), 364–370 (2021).
  Medline CASGoogle Scholar
• 27. Koster RA, Niemeijer P, Veenhof H, Hateren KV, Alffenaar JC, Touw DJ. A volumetric absorptive microsampling LC–MS/MS method for five immunosuppressants and their hematocrit effects. Bioanalysis 11(6), 495–508 (2019).
  CASGoogle Scholar
• 28. Heussner K, Rauh M, Cordasic N et al. Adhesive blood microsampling systems for steroid measurement via LC–MS/MS in the rat. Steroids 120, 1–6 (2017).
  Medline CASGoogle Scholar
• 29. Paniagua-Gonzalez L, Diaz-Louzao C, Lendoiro E et al. Volumetric absorptive microsampling (VAMS) for assaying immunosuppressants from venous whole blood by LC–MS/MS using a novel atmospheric pressure ionization probe (UniSpray). J. Pharm. Biomed. Anal. 189, 113422 (2020).
  Medline CASGoogle Scholar
• 30. Marshall DJ, Adaway JE, Hawley JM, Keevil BG. Quantification of testosterone, androstenedione and 17-hydroxyprogesterone in whole blood collected using Mitra microsampling devices. Ann. Clin. Biochem. 57(5), 351–359 (2020).
  Medline CASGoogle Scholar
• 31. Levin JM, Frederick B de B, Ross MH et al. Influence of baseline hematocrit and hemodilution on BOLD fMRI activation. Magn. Reson. Imaging 19(8), 1055–1062 (2001).
  Medline CASGoogle Scholar
• 32. Huber W, Umgelter A, Reindl W et al. Volume assessment in patients with necrotizing pancreatitis: a comparison of intrathoracic blood volume index, central venous pressure, and hematocrit, and their correlation to cardiac index and extravascular lung water index. Crit. Care Med. 36(8), 2348–2354 (2008).
  MedlineGoogle Scholar
• 33. Miao Z, Farnham JG, Hanson G, Podoll T, Reid MJ. Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC–MS/MS. Bioanalysis 7(16), 2071–2083 (2015).
  CASGoogle Scholar
• 34. Londhe V, Rajadhyaksha M. Opportunities and obstacles for microsampling techniques in bioanalysis: special focus on DBS and VAMS. J. Pharm. Biomed. Anal. 182, 113102 (2020).
  Medline CASGoogle Scholar
• 35. Parker SL, Roberts JA, Lipman J, Wallis SC. Quantitative bioanalytical validation of fosfomycin in human whole blood with volumetric absorptive microsampling. Bioanalysis 7(19), 2585–2595 (2015).
  CASGoogle Scholar
• 36. Kulkarni P, Karanam A, Gurjar M et al. Effect of various anticoagulants on the bioanalysis of drugs in rat blood: implication for pharmacokinetic studies of anticancer drugs. Springerplus 5(1), 102 (2016).
  MedlineGoogle Scholar
• 37. Miao Z, Farnham JG, Hanson G, Podoll T, Reid MJ. Bioanalysis of emixustat (ACU-4429) in whole blood collected with volumetric absorptive microsampling by LC–MS/MS. Bioanalysis 7(16), 2071–2083 (2015).
  CASGoogle Scholar
• 38. Denniff P, Spooner N. Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis. Anal. Chem. 86(16), 8489–8495 (2014). •• Original work demonstrating the Mitra VAMS device.
  Medline CASGoogle Scholar
• 39. Gao X, Chen C, Geng D et al. Volumetric absorptive microsampling (VAMS) in therapeutic protein quantification by LC–MS/MS: investigation of anticoagulant impact on assay performance and recommendations for best practices in method development. J. Pharm. Biomed. Anal. 196, 113895 (2021). •• A key demonstration of how the presence of anticoagulant in VAMS calibrators can have an impact on assay integrity.
  Medline CASGoogle Scholar
• 40. Kita K, Mano Y. Application of volumetric absorptive microsampling device for quantification of tacrolimus in human blood as a model drug of high blood cell partition. J. Pharm. Biomed. Anal. 143, 168–175 (2017). • Bioanalytical method validation of an assay for tacrolimus collected using Mitra VAMS, and assessment of Mitra hematocrit bias for a drug with high blood-to-plasma partioning.
  Medline CASGoogle Scholar
• 41. Barco S, Castagnola E, Moscatelli A, Rudge J, Tripodi G, Cangemi G. Volumetric adsorptive microsampling-liquid chromatography tandem mass spectrometry assay for the simultaneous quantification of four antibiotics in human blood: method development, validation and comparison with dried blood spot. J. Pharm. Biomed. Anal. 145, 704–710 (2017).
  Medline CASGoogle Scholar