{"id":"W4406823881","doi":"10.1080/17576180.2025.2450194","title":"2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( <u>Part 1A</u> – Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis <u>Part 1B</u> - Regulatory Agencies’ Inputs on Regulated Bioanalysis/BMV)","year":2025,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":10,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Revolution Medicines; Regeneron Pharmaceuticals; Biogen; GlaxoSmithKline; Health Canada; AstraZeneca; U.S. Food and Drug Administration; Ministry of Health, Labour and Welfare; Eli Lilly and Company","keywords":"Bioanalysis; Mass spectrometry; Urine; Chemistry; Chromatography; Computational biology; Biochemistry; Biology","routes":{"ca_aff":true,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","bibliometrics","sts","research_integrity","insufficient_payload"],"consensus_categories":["metaepi_narrow"],"category_scores_codex":[0.007657081,0.001882311,0.003947517,0.01037496,0.001303874,0.0007590998,0.0008821571,0.001696486,0.001524391],"category_scores_gemma":[0.001298886,0.001678625,0.002274991,0.02234167,0.001353256,0.0007742643,0.0002071569,0.00120493,0.0000732118],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001207335,"about_ca_system_score_gemma":0.0002768853,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0003012452,"about_ca_topic_score_gemma":0.002184354,"domain_scores_codex":[0.9842566,0.004867613,0.004350232,0.003972722,0.0008539005,0.001698883],"domain_scores_gemma":[0.9910128,0.002451593,0.002141286,0.003113189,0.0009519694,0.0003291952],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.02125638,0.01314333,0.06413815,0.001205526,0.2737077,0.0001902821,0.0007186541,0.0384124,0.4906148,0.03144906,0.02703802,0.03812572],"study_design_scores_gemma":[0.01667921,0.006682133,0.1683919,0.00224108,0.05962663,0.0000177233,0.003598418,0.1507448,0.513554,0.007175977,0.06347226,0.007815775],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9088542,0.00649246,0.03471983,0.02339859,0.002799991,0.008873822,0.005201455,0.005149113,0.004510514],"genre_scores_gemma":[0.8954558,0.003721736,0.08378815,0.000798967,0.0001926901,0.0006938922,0.007761498,0.0001942041,0.007393006],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.2140811,"threshold_uncertainty_score":0.9999963,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02547417739506265,"score_gpt":0.3608453096452852,"score_spread":0.3353711322502225,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}