{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.02124088,0.001851817,0.001327866,0.002165086,0.002733217,0.01251569,0.003470191,0.01225488,0.0287465],"category_scores_gemma":[0.02243537,0.0009375165,0.001586224,0.002283063,0.003497614,0.007254641,0.004484579,0.009461372,0.03174928],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004751135,"about_ca_system_score_gemma":0.0132823,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003629014,"about_ca_topic_score_gemma":0.005527479,"domain_scores_codex":[0.9859145,0.001866759,0.001207032,0.001786707,0.008109654,0.001115311],"domain_scores_gemma":[0.9682328,0.005375337,0.003581284,0.00168331,0.01600707,0.00512016],"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":[0.00006315362,0.0000710125,0.0001829915,0.0004456137,0.0000104958,0.0001436666,0.000171813,0.0001685734,0.002416356,0.005198971,0.9279601,0.06316735],"study_design_scores_gemma":[0.000004823134,0.00003068395,0.0001689624,0.000231537,0.000004121972,0.00007972684,0.00006549263,0.0000629505,0.00122646,0.00156653,0.9965478,0.0000110939],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"editorial","genre_gemma":"methods","genre_scores_codex":[0.002528805,0.07084249,0.01564497,0.3381209,0.4622636,0.0007357124,0.001646849,0.001085214,0.1071315],"genre_scores_gemma":[0.01655424,0.07681962,0.01579418,0.1601094,0.1850243,0.0006966126,0.004118029,0.001902588,0.538981],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.0287465,"threshold_uncertainty_score":0.1123338,"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."}}