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Microsampling bibliography

Key papers and resources on the topic of microsampling.

General

Londhe V et al. (2022). Pertinence of microsampling in various nonclinical and clinical studies: the ICH perspective. Bioanalysis 14(17):1137-1139. doi: 10.4155/bio-2022-0163

Williams K et al. (2021). Assessment of low volume sampling technologies: utility in nonclinical and clinical studies. Bioanalysis 13(9): 679–91. doi: 10.4155/bio-2021-0027

Wickremsinhe E et al. (2020). Land O’Lakes Workshop on Microsampling: Enabling Broader Adoption. The AAPS Journal 22: 135. doi: 10.1208/s12248-020-00524-2

Patel S et al. (2019). Microsampling for quantitative bioanalysis, an industry update: output from an AAPS/EBF survey. Bioanalysis 11(7): 619–28. doi: 10.4155/bio-2019-0019

Spooner N et al. (2019). Microsampling: considerations for its use in pharmaceutical drug discovery and development. Bioanalysis 11(10): 1015–38. doi: 10.4155/bio-2019-0041

Coleman D et al. (2017). Capillary microsampling in nonclinical safety assessment: practical sampling and bioanalysis from a CRO perspective.  Bioanalysis 9(10): 787–98. doi: 10.4155/bio-2017-0032

Poitout-Belissent F et al. (2016). Reducing blood volume requirements for clinical pathology testing in toxicologic studies—points to consider. Veterinary Clinical Pathology 45: 534–51. doi: 10.1111/vcp.12429

Chapman K et al. (2014). Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies. Drug Discovery Today 19(5): 528–32. doi: 10.1016/j.drudis.2014.01.002

Chapman K et al. (2014). Reducing pre-clinical blood volume for toxicokinetics: toxicologists, pathologists and bioanalysts unite. Bioanalysis 6(22): 2965–8. doi: 10.4155/bio.14.204

Capillary microsampling – rodents

Takahashi K et al. (2024). Impact of microsampling on toxicological evaluation in rodent safety studies. Journal of applied toxicology 44(1):118-128. doi: 10.1002/jat.4523

Hattori N et al. (2023). Effect of microsampling (50 μL) on toxicological evaluation of methapyrilene, a hepatotoxic substance, in a collaborative 28-day study in female rats. Journal of toxicological sciences 48(1):1-14. doi: 10.2131/jts.48.1

Karp N et al. (2023). Impact of repeated micro and macro blood sampling on clinical chemistry and haematology in rats for toxicokinetic studies. Regulatory toxicology and pharmacology 141:105386. doi: 10.1016/j.yrtph.2023.105386

Yuan L et al. (2023). A validated capillary microsampling liquid chromatography–tandem mass spectrometry method for quantification of antisense oligonucleotides in mouse serum. Bioanalysis 15: 683-694. doi: 10.4155/bio-2023-0096

Ohtsuka H et al. (2022). No obvious toxicological influences of 50 μL microsampling from rats administered phenacetin as a drug with hematological toxicity. Journal of toxicological sciences 47(5):193-199. doi: 10.2131/jts.47.193

Tochitani T et al. (2022). Effects of microsampling on toxicity assessment of hematotoxic compounds in a general toxicity study in rats. Journal of toxicological sciences 47(7):269-276. doi: 10.2131/jts.47.269

Hotta K et al. (2021). Quantitative and qualitative application of a novel capillary microsampling device, Microsampling WingTM(MSW), using antiepileptic drugs in rats. Journal of Pharmaceutical and Biomedical Analysis 194: e113788. doi: 10.1016/j.jpba.2020.113788

Lee et al. (2021). Serial blood sampling effects in rat embryo-fetal development studies for toxicokinetics. Regulatory Toxicology & Pharmacology 123: e104930. doi: 10.1016/j.yrtph.2021.104930

Hattori N et al. (2020). Effects of serial cervical or tail blood sampling on toxicity and toxicokinetic evaluation in rats. The Journal of Toxicological Sciences 45: 599–609. doi: 10.2131/jts.45.599

Raje A et al. (2020). Capillary microsampling in mice: effective way to move from sparse sampling to serial sampling in pharmacokinetics profiling. Xenobiotica 50(6): 663–669. doi: 10.1080/00498254.2019.1683259

Yokoyama et al. (2020). Lack of toxicological influences by microsampling (50 µL) from jugular vein of rats in a collaborative 28-day study. The Journal of Toxicological Sciences 45(6): 319–25. doi: 10.2131/jts.45.319

Hackett M et al. (2019). A Factorial Analysis of Drug and Bleeding Effects in Toxicokinetic Studies. Toxicological Sciences 170(1): 234–46. doi: 10.1093/toxsci/kfz092

Kita K et al. (2019). Application of a Volumetric Absorptive Microsampling Device to a Pharmacokinetic Study of Tacrolimus in Rats: Comparison with Wet Blood and Plasma. European Journal of Drug Metabolism and Pharmacokinetics 44: 91–102. doi: 10.1007/s13318-018-0493-7

Verhaeghe T et al. (2019). Comparison of toxicokinetic parameters of a drug and two metabolites following traditional and capillary microsampling in rat. Bioanalysis 11(13): 1233–42. doi: 10.4155/bio-2019-0085

Imholt C et al. (2018). Establishment and validation of microsampling techniques in wild rodents for ecotoxicological research. Journal of Applied Toxicology 38(9): 1244–50. doi: 10.1002/jat.3635

Li H et al. (2018). Application of Mitra® microsampling for pharmacokinetic bioanalysis of monoclonal antibodies in rats. Bioanalysis 11(1): 13–20. doi: 10.4155/bio-2018-0228

Beekhuijzen M et al. (2017). Satellite rats are redundant in embryo-fetal development studies. Reproductive Toxicology 72: 122–8. doi: 10.1016/j.reprotox.2017.06.042

Mitchard T et al. (2017). ). Investigation into the effect of microsampling on mouse fetuses and pregnant mice in the embryofetal development study design. Reproductive Toxicology 67: 140-145. doi: 10.1016/j.reprotox.2016.12.006

Verhaeghe T et al. (2017). The application of capillary microsampling in GLP toxicology studies. Bioanalysis 9(7): 531–40. doi: 10.4155/bio-2016-0297

Harstad E et al. (2016). Balancing Blood Sample Volume with 3Rs: Implementation and Best Practices for Small Molecule Toxicokinetic Assessments in Rats. ILAR Journal 57(2): 157–165. doi: 10.1093/ilar/ilw023

Niu X et al. (2016). Effects of Capillary Microsampling on Toxicological Endpoints in Juvenile Rats. Toxicological Sciences 154(1): 69–77. doi: 10.1093/toxsci/kfw146

Patel N et al. (2016). Evaluation and Optimization of Blood Micro-Sampling Methods: Serial Sampling in a Cross-Over Design from an Individual Mouse. Journal of Pharmaceutical Sciences 19(4): 496-510. doi: 10.18433/J3NK60

Caron A et al. (2015). Clinical and anatomic pathology effects of serial blood sampling in rat toxicology studies, using conventional or microsampling methods. Regulatory Toxicology and Pharmacology 72(2015): 429–39. doi: 10.1016/j.yrtph.2015.05.022

Korfmacher W et al. (2015). Utility of capillary microsampling for rat pharmacokinetic studies: Comparison of tail-vein bleed to jugular vein cannula sampling. Journal of Pharmacological and Toxicological Methods 76: 7–14. doi: 10.1016/j.vascn.2015.07.001

Joyce A et al. (2014). One Mouse, One Pharmacokinetic Profile: Quantitative Whole Blood Serial Sampling for Biotherapeutics. Pharmaceutical Research  31: 1823–33. doi: 10.1007/s11095-013-1286-y

Powles-Glover N et al. (2014). Assessment of haematological and clinical pathology effects of blood microsampling in suckling and weaned juvenile rats. Regulatory Toxicology & Pharmacology 69: 425–33. doi: 10.1016/j.yrtph.2014.05.006

Powles-Glover N et al. (2014). Assessment of toxicological effects of blood microsampling in the vehicle dosed adult rat. Regulatory Toxicology & Pharmacology 68(3): 325–31. doi: 10.1016/j.yrtph.2014.01.001

Dillen L et al. (2014). Blood microsampling using capillaries for drug-exposure determination in early preclinical studies: a beneficial strategy to reduce blood sample volumes. Bioanalysis 6(3): 293–306. doi: 10.4155/bio.13.286

Sadler A and Bailey S (2013). Validation of a refined technique for taking repeated blood samples from juvenile and adult mice. Laboratory Animals 47(4): 316–9. doi: 10.1177/0023677213494366

Capillary microsampling – non-rodents

Bertani S et al. (2023). Blood microsampling in cynomolgus monkey and evaluation of plasma PK parameters in comparison to conventional sampling. Journal of Pharmacological and Toxicological Methods 123:107298. doi:  10.1016/j.vascn.2023.107298

Wang Y et al. (2021). Application of blood microsampling in cynomolgus monkey and demonstration of equivalent monoclonal antibody PK parameters compared to conventional sampling. Pharmaceutical Research 38(5): 819–30. doi:  10.1007/s11095-021-03044-6

Mochizuki H et al. (2018). Approaches of validation of a 2-week combined repeated oral dose toxicity study with plasma microsampling toxicokinetics in common marmoset. The Journal of Toxicological Sciences 43: 685–95. doi: 10.2131/jts.43.685

Caron A et al. (2015). Miniaturized Blood Sampling Techniques to Benefit Reduction in Mice and Refinement in Nonhuman Primates: Applications to Bioanalysis in Toxicity Studies with Antibody–Drug Conjugates. Journal of the American Association for Laboratory Animal Science 54: 145–52. PMID: 25836960

Lefevre A et al. (2015). Blood microsampling from the ear capillary in non-human primates. Laboratory Animals 49(4): 349–52. doi: 10.1177/0023677215586911

Capillary microsampling – bioanalysis considerations

Protti M et al. (2022). Volumetric Absorptive Microsampling (VAMS) for Targeted LC-MS/MS Determination of Tryptophan-Related Biomarkers. Molecules 27(17):5652. doi: 10.3390/molecules27175652

Cobb Z et al. (2019). Feedback from the European Bioanalysis Forum liquid microsampling consortium: capillary liquid microsampling and assessment of homogeneity of the resultant samples. Bioanalysis 11(6): 525–32. doi: 10.4155/bio-2019-0017

Timmerman P et al. (2014). European Bioanalysis Forum continued plans to support liquid microsampling. Bioanalysis 6(14): 1897–900. doi: 10.4155/bio.14.99

White et al. (2014). European Bioanalysis Forum - Reflection on requirements for bioanalytical assays used to support liquid microsampling. Bioanalysis 6(19): 2581–6. doi: 10.4155/bio.14.211 

Bowen CL et al. (2013). A novel approach to capillary plasma microsampling for quantitative bioanalysis. Bioanalysis 5(9): 1131–5. doi: 10.4155/bio.13.58

Nilsson LB et al. (2013). Capillary microsampling in the regulatory environment: validation and use of bioanalytical capillary microsampling methods. Bioanalysis 5(6): 731–8. doi: 10.4155/bio.13.27

Spreadborough MJ et al. (2013). Bioanalytical implementation of plasma capillary microsampling: small hurdles, large gains. Bioanalysis 5(12): 1485–9. doi: 10.4155/bio.13.120

Jonsson O et al. (2012). Capillary microsampling of 25 μl blood for the determination of toxicokinetic parameters in regulatory studies in animals. Bioanalysis 4(6): 661–74. doi: 10.4155/bio.12.25

Jonsson O et al. (2012). Validation of a bioanalytical method using capillary microsampling of 8 μl plasma samples: application to a toxicokinetic study in mice. Bioanalysis 4(16): 1989–98. doi: 10.4155/bio.12.177

Smith C et al. (2011). Evaluation of blood microsampling techniques and sampling sites for the analysis of drugs by HPLC-MS. Bioanalysis 3(2): 145–56. doi: 10.4155/bio.10.193

Dried blood spot analysis

Wickremsinhe E et al. (2016). Impact of Repeated Tail Clip and Saphenous Vein Phlebotomy on Rats Used in Toxicology Studies. Toxicologic Pathology 44(7): 1013–20. doi: 10.1177/0192623316656285

Evans C et al. (2015). Implementing Dried Blood Spot Sampling for Clinical Pharmacokinetic Determinations: Considerations from the IQ Consortium Microsampling Working Group. The AAPS Journal 17(2): 292–300. doi: 10.1208/s12248-014-9695-3

Wickremsinhe E and Perkins E (2015). Using Dried Blood Spot Sampling to Improve Data Quality and Reduce Animal Use in Mouse Pharmacokinetic Studies. Journal of the American Association for Laboratory Animal Science 54(2): 139–44. PMID: 25836959

Denniff P and Spooner N (2014). Volumetric Absorptive Microsampling: A dried sample collection technique for quantitative bioanalysis. Analytical Chemistry 86(16): 8489–95. doi: 10.1021/ac5022562

de Vries R et al. (2013). The effect of hematocrit on bioanalysis of DBS: results from the EBF DBS-microsampling consortium. Bioanalysis 5(17): 2147–60. doi: 10.4155/bio.13.170

Timmerman P et al. (2013). Update of the EBF recommendation for the use of DBS in regulated bioanalysis integrating the conclusions from the EBF DBS-microsampling consortium. Bioanalysis 5(17): 2129–36. doi: 10.4155/bio.13.173

van Baar B et al. (2013). IS addition in bioanalysis of DBS: results from the EBF DBS-microsampling consortium. Bioanalysis 5(17): 2137–45. doi: 10.4155/bio.13.172

Cobb Z et al. (2013). In-depth study of homogeneity in DBS using two different techniques: results from the EBF DBS-microsampling consortium. Bioanalysis 5(17): 2161–69. doi: 10.4155/bio.13.171

Dainty TC et al. (2012). Dried blood spot bioanalysis: an evaluation of techniques and opportunities for reduction and refinement in mouse and juvenile rat toxicokinetic studies. International Journal of Toxicology 31(1): 4-13. doi: 10.1177/1091581811429493

Barfield M et al. (2011). GlaxoSmithKline’s experience of incurred sample reanalysis for dried blood spot samples. Bioanalysis 3(9): 1025-1030. doi: 10.4155/bio.11.56

Burnett JE (2011). Dried blood spot sampling: practical considerations and recommendation for use with preclinical studies. Bioanalysis 3(10): 1099–107. doi: 10.4155/bio.11.68

Clark GT and Haynes JJ (2011). Utilization of DBS within drug discovery: A simple 2D-LC-MS/MS system to minimize blood and paper based matrix effects from FTA Elute™ dried blood spots. Bioanalysis 3(11): 1253–70. doi: 10.4155/bio.11.81

Clark GT et al. (2011). Utilization of DBS within drug discovery: Modification of a standard DiLab(R) AccuSampler(R) to facilitate automatic dried blood spot sampling. Laboratory Animals 45(2): 124–6. doi: 10.1258/la.2010.010155

Li F et al. (2011). Perforated dried blood spots: a novel format for accurate microsampling. Bioanalysis 3(20): 2321–33. doi: 10.4155/bio.11.219 

O’Mara M et al. (2011). The effect of hematocrit and punch location on assay bias during quantitative bioanalysis of dried blood spot samples. Bioanalysis 3(20): 2335–47. doi: 10.4155/bio.11.220

Ooms JA et al. (2011). Exploration of a new concept for automated dried blood spot analysis using flow-through desorption and online SPE-MS/MS. Bioanalysis 3(20): 2311–2320. doi: 10.4155/bio.11.214

Roberts S et al. (2011). The application of blood spot technology to determine pharmacokinetic parameters for safety pharmacology studies. Journal of Pharmacological and Toxicological Methods 64(1): 51. doi: 10.1016/j.vascn.2011.03.176

Stokes AH et al. (2011). Determination of drug concentrations using dried blood spots: investigation of blood sampling and collection techniques in Crl:CD(SD) rats. Laboratory Animals 45(2): 109–13. doi: 10.1258/la.2010.010147

Clark GT et al. (2010). Utilization of DBS within drug discovery: Development of a serial microsampling pharmacokinetic study in mice. Bioanalysis 2(8): 1477–88. doi: 10.4155/bio.10.91

Denniff P and Spooner N (2010). The effect of hematocrit on assay bias when using DBS samples for the quantitative analysis of drugs. Bioanalysis 2(8): 1385–95. doi: 10.4155/bio.10.103

Liu G et al. (2010). Evaluating and defining sample preparation procedures for DBS LC–MS/MS assays. Bioanalysis 2(8): 1405–14. doi: 10.4155/bio.10.106

Barfield M et al. (2008). Application of dried blood spots combined with HPLC-MS/MS for the quantification of acetaminophen in toxicokinetic studies. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences 870(1): 32–7. doi: 10.1016/j.jchromb.2008.05.025

Other microsampling resources