{"id":"W2774347927","doi":"10.4155/bio-2017-4973","title":"2017 White Paper on Recent Issues in Bioanalysis: Rise of Hybrid LBA/LCMS Immunogenicity Assays (Part 2: Hybrid LBA/LCMS Biotherapeutics, Biomarkers & Immunogenicity Assays and Regulatory Agencies’ Inputs)","year":2017,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":36,"is_retracted":false,"has_abstract":true,"ca_institutions":"Caprion (Canada); Health Canada","funders":"Health Canada; Genentech; Angelini Pharma; Sanofi; Amgen; Pfizer; U.S. Food and Drug Administration; Ministry of Health, Labour and Welfare; Bristol-Myers Squibb; Agence Nationale de Sécurité du Médicament et des Produits de Santé; GlaxoSmithKline","keywords":"Immunogenicity; Bioanalysis; Biopharmaceutical; Regulatory science; Computer science; Chemistry; Biotechnology; Medicine; 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":[0.01974894,0.001629072,0.001084274,0.002534921,0.00357561,0.01447463,0.002696814,0.009669353,0.0377395],"category_scores_gemma":[0.0214641,0.001032059,0.00136461,0.002126844,0.003509278,0.007378999,0.003846511,0.01066989,0.04246944],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004846343,"about_ca_system_score_gemma":0.01560243,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002520529,"about_ca_topic_score_gemma":0.004975799,"domain_scores_codex":[0.9833443,0.001871738,0.0009835294,0.001685707,0.01074905,0.001365752],"domain_scores_gemma":[0.9645681,0.006509667,0.00273,0.001458355,0.0195033,0.005230609],"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":[0.0000444724,0.00004477159,0.0001047286,0.0002226548,0.00000798713,0.0001010537,0.0001402908,0.0000777764,0.001467723,0.004688319,0.9614205,0.0316797],"study_design_scores_gemma":[0.000004945508,0.00002435507,0.00009339226,0.000135956,0.000004656929,0.0000360845,0.0001001032,0.00004480988,0.001232533,0.001249349,0.997062,0.00001177517],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"editorial","genre_gemma":"methods","genre_scores_codex":[0.002334898,0.02902514,0.01510721,0.2576199,0.5622528,0.0007852117,0.001799861,0.00138234,0.1296927],"genre_scores_gemma":[0.01370583,0.05299978,0.01721402,0.1355721,0.1829554,0.00103065,0.00504674,0.003029019,0.5884464],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.0377395,"threshold_uncertainty_score":0.1262513,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04165581480862591,"score_gpt":0.3114225046959653,"score_spread":0.2697666898873394,"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."}}