{"id":"W2551983394","doi":"10.4155/bio-2016-4989","title":"2016 White Paper on Recent Issues in Bioanalysis: Focus on Biomarker Assay Validation (BAV): (Part 3 – Lba, Biomarkers and Immunogenicity)","year":2016,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":59,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"Agenzia Italiana del Farmaco, Ministero della Salute; Health Canada; U.S. Food and Drug Administration; Ministry of Health, Labour and Welfare; World Health Organization; Sanofi","keywords":"Bioanalysis; Immunogenicity; Biopharmaceutical; Biosimilar; Excellence; Computer science; Nanotechnology; Medicine; Political science; Biotechnology; 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","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.002075528,0.0005283015,0.0008986374,0.001130261,0.0001957021,0.00006843492,0.0003676573,0.0006404822,0.004706125],"category_scores_gemma":[0.0005562333,0.0003190734,0.0004647688,0.00154992,0.0005093433,0.0001802861,0.000138468,0.0002411868,0.0005176108],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001929652,"about_ca_system_score_gemma":0.00004972616,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0002812865,"about_ca_topic_score_gemma":0.0002402509,"domain_scores_codex":[0.9955839,0.001471602,0.000952011,0.001101027,0.0001860524,0.0007054303],"domain_scores_gemma":[0.9978528,0.0006541445,0.0003271968,0.0009059923,0.0001569043,0.0001029745],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.001567022,0.0008531266,0.02739771,0.00002045136,0.006806134,0.00002502781,0.00007602037,0.000001750472,0.2364987,0.0007846835,0.01056984,0.7153995],"study_design_scores_gemma":[0.004843192,0.0008341738,0.04343311,0.0005134069,0.002553829,0.00001554018,0.0002715247,0.00004681279,0.2621569,0.001488064,0.6822808,0.001562665],"study_design_candidate":"design_other","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.3472396,0.2105056,0.003717619,0.3577669,0.006004407,0.004009712,0.002095934,0.001173072,0.06748717],"genre_scores_gemma":[0.9621602,0.02029128,0.0007748503,0.00123768,0.00009421394,0.00006694441,0.00009861535,0.00006237008,0.0152139],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.7138368,"threshold_uncertainty_score":0.9999261,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02676179794242258,"score_gpt":0.2850547170723799,"score_spread":0.2582929191299574,"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."}}