{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.05304876,0.002285684,0.001769509,0.003272749,0.004014043,0.01602041,0.007929947,0.02551384,0.04661954],"category_scores_gemma":[0.0465279,0.001708947,0.00206975,0.003616785,0.005860564,0.007160073,0.004623104,0.01274278,0.06055087],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.006296223,"about_ca_system_score_gemma":0.02831115,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01183405,"about_ca_topic_score_gemma":0.01816984,"domain_scores_codex":[0.9509346,0.01062006,0.004306449,0.004939816,0.02689098,0.002308115],"domain_scores_gemma":[0.9016943,0.02297775,0.008224246,0.00503146,0.05470191,0.00737037],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00007135789,0.00009978424,0.0001879826,0.0003158481,0.00001198037,0.00014679,0.0001021418,0.0001140388,0.001212959,0.004212969,0.9494985,0.04402573],"study_design_scores_gemma":[0.00001467419,0.00003959086,0.0003652413,0.0002940447,0.000007784803,0.00008015296,0.00004353209,0.0001003325,0.0008979232,0.001277523,0.9968628,0.00001648327],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.001886917,0.04227713,0.02963498,0.4651412,0.2055042,0.00211423,0.004864945,0.002631835,0.2459445],"genre_scores_gemma":[0.007692476,0.02223037,0.02460362,0.2720133,0.06151195,0.00139358,0.006352605,0.002426197,0.601776],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.05304876,"threshold_uncertainty_score":0.280552,"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."}}