{"id":"W2774120458","doi":"10.4155/bio-2017-4974","title":"2017 White Paper on Recent Issues in Bioanalysis: A Global Perspective on Immunogenicity Guidelines & Biomarker Assay Performance (Part 3 – Lba: Immunogenicity, Biomarkers and PK Assays)","year":2017,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":67,"is_retracted":false,"has_abstract":true,"ca_institutions":"Caprion (Canada); Health Canada; inVentiv Health Clinical","funders":"Health Canada; Genentech; Agence Nationale de Sécurité du Médicament et des Produits de Santé; Angelini Pharma; Sanofi; U.S. Food and Drug Administration; Bristol-Myers Squibb; Ministry of Health, Labour and Welfare; Pfizer; Amgen","keywords":"Bioanalysis; Immunogenicity; Biopharmaceutical; Excellence; Regulatory science; Biosimilar; Computer science; Nanotechnology; Chemistry; Political science; Medicine; Biotechnology; Biology; Chromatography","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":[0.04209046,0.002333742,0.002195698,0.003710474,0.0030917,0.01798558,0.005655756,0.017769,0.02255825],"category_scores_gemma":[0.04641116,0.001330245,0.001699982,0.003680318,0.007487417,0.01070056,0.005656493,0.01816984,0.03458161],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00583905,"about_ca_system_score_gemma":0.02620829,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004313238,"about_ca_topic_score_gemma":0.005595778,"domain_scores_codex":[0.9716371,0.005240378,0.002736293,0.002383839,0.01613086,0.001871657],"domain_scores_gemma":[0.9157956,0.02117008,0.008467874,0.00288068,0.04241488,0.009270816],"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":[0.00003205941,0.00004708385,0.00008342203,0.0003796068,0.00000753969,0.0000898213,0.0001531666,0.0001337187,0.0006348142,0.006432292,0.9535887,0.03841782],"study_design_scores_gemma":[0.000004161435,0.00002041102,0.00009681198,0.000395415,0.00000424121,0.00005073719,0.000102885,0.00005410752,0.0004662841,0.002291154,0.9965004,0.00001335319],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.000873793,0.07264184,0.01414277,0.5306148,0.3146376,0.0005032679,0.001251973,0.0009041961,0.06442977],"genre_scores_gemma":[0.009772649,0.1336187,0.02334259,0.3427475,0.2082819,0.001100595,0.004144845,0.003092673,0.2738985],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.04209046,"threshold_uncertainty_score":0.2225983,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08757148376182888,"score_gpt":0.3844078216666881,"score_spread":0.2968363379048592,"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."}}