A Data Driven Strategy and Case Study for Implementation of Singlicate Analysis in Ligand Binding Assays Used for PK Quantitation
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Publisher
Springer Science and Business Media LLC
Link
https://link.springer.com/content/pdf/10.1208/s12248-024-00959-x.pdf
Reference10 articles.
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2. 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.
3. 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.
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