Birnboeck HF, Schick E, Justies N. Singlicate analysis in regulated bioanalysis using ligand-binding assays: where are we heading? Bioanalysis. 2017;9(18):1357–9.

Article  CAS  PubMed  Google Scholar 

Booth B, Stevenson L, Pillutla R, Buonarati M, Beaver C, Fraier D, et al. 2019 White Paper On Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs (Part 2 - Recommendations on 2018 FDA BMV Guidance, 2019 ICH M10 BMV Draft Guideline and Regulatory Agencies’ Input on Bioanalysis, Biomarkers and Immunogenicity). Bioanalysis. 2019;11(23):2099–132.

Article  PubMed  Google Scholar 

Szapacs M, Jian W, Spellman D, Cunliffe J, Verburg E, Kaur S, et al. 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis. 2023;15(16):955–1016.

Article  CAS  PubMed  Google Scholar 

Barfield M, Goodman J, Hood J, Timmerman P. European Bioanalysis Forum recommendation on singlet analysis for ligand binding assays: time for a new mindset. Bioanalysis. 2020;12(5):273–84.

Article  CAS  PubMed  Google Scholar 

Clark TH, Yates PD, Chunyk AG, Joyce AP, Wu A, Pop-Damkov P, et al. Feasibility of Singlet Analysis for Ligand Binding Assays: a Retrospective Examination of Data Generated Using the Gyrolab Platform. AAPS J. 2016;18(5):1300–8.

Article  CAS  PubMed  Google Scholar 

Jiang H, Kozhich A, Cummings J, Gambardella J, Zambito F, Titsch C, et al. Singlicate Ligand Binding Assay Using an Automated Microfluidic System: a Clinical Case Study. AAPS J. 2017;19(5):1461–8.

Article  CAS  PubMed  Google Scholar 

Pillutla R, Gorovits B, GleasonQuirozChristopherBraunBrockusDonaldsonHaslbergerHeQianSydorWickremsinheWilliams CJDMCDTLMJEL. Recommendations for singlicate-based approach in ligand binding assays: an IQ Consortium perspective. Bioanalysis. 2020;12(12):823–34.

Article  CAS  PubMed  Google Scholar 

US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Silver Spring, MD, USA. Guidance for Industry, M10 Bioanalytical Method Validation and Study Sample Analysis, Nov 2022.

Stanta JL, Craig H, Smith C, Chappell J. Comparing singlet and duplicate immunogenicity assay in human plasma for pembrolizumab using Gyrolab. Bioanalysis. 2021;13(11):891–900.

Article  CAS  PubMed  Google Scholar 

Hendricks WA, Robey KW. The Sampling Distribution of the Coefficient of Variation. Ann Math Stat. 1936;7(3):129–32. https://doi.org/10.1214/aoms/1177732503.JSTOR2957564.

Article  Google Scholar