{"id":"W4399577440","doi":"10.1080/17576180.2024.2342691","title":"16 <sup>th</sup> GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status","year":2024,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"Grand Challenges Canada; Pharma Medica Research (Canada); Aptose Biosciences (Canada)","funders":"","keywords":"Bioanalysis; Harmonization; Immunogenicity; Flow cytometry; Computational biology; Chemistry; Medicine; Biology; Chromatography; Molecular biology; Immunology; Physics","routes":{"ca_aff":true,"ca_fund":false,"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":[0.01867875,0.002030235,0.001105663,0.001719443,0.003546778,0.005799037,0.002800823,0.01421736,0.0656421],"category_scores_gemma":[0.01943842,0.0005598177,0.00116625,0.00114945,0.003844222,0.001666447,0.003512072,0.004230597,0.04061941],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.006699518,"about_ca_system_score_gemma":0.01729799,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.02515867,"about_ca_topic_score_gemma":0.03035113,"domain_scores_codex":[0.9910536,0.002137554,0.0007743244,0.0005503446,0.003814295,0.001669872],"domain_scores_gemma":[0.9687343,0.007088668,0.003343022,0.001221795,0.01563974,0.003972542],"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":[0.0003824643,0.00006486112,0.000705217,0.0004879522,0.00001460694,0.000569123,0.0002565258,0.0003244366,0.004333787,0.002832817,0.9594542,0.03057399],"study_design_scores_gemma":[0.00004784813,0.0002436498,0.003547235,0.0004961427,0.00002744853,0.0002175388,0.000424484,0.0002705384,0.006196418,0.001710446,0.9867692,0.00004912485],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.02027524,0.02469743,0.01973667,0.3399949,0.114328,0.005289583,0.01586043,0.003792069,0.4560256],"genre_scores_gemma":[0.04780172,0.007403949,0.02101564,0.1405747,0.02077916,0.003620903,0.0161799,0.002173933,0.7404501],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.0656421,"threshold_uncertainty_score":0.2195947,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02447590168580123,"score_gpt":0.3404678279722946,"score_spread":0.3159919262864934,"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."}}