{"id":"W2142933086","doi":"10.1586/17474124.2015.1091306","title":"The scientific and regulatory rationale for indication extrapolation: a case study based on the infliximab biosimilar CT-P13","year":2015,"lang":"en","type":"review","venue":"Expert Review of Gastroenterology & Hepatology","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":20,"is_retracted":false,"has_abstract":true,"ca_institutions":"McMaster University","funders":"Health Canada","keywords":"Biosimilar; Infliximab; Medicine; Inflammatory bowel disease; Disease; Extrapolation; Intensive care medicine; Internal medicine","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":[0.01254857,0.0007355651,0.00117558,0.001614266,0.001296969,0.003529882,0.001090601,0.005713612,0.004485471],"category_scores_gemma":[0.02256495,0.0003526028,0.001487148,0.001733374,0.002404008,0.003249105,0.001780127,0.004862394,0.001195742],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001934696,"about_ca_system_score_gemma":0.003074707,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00132608,"about_ca_topic_score_gemma":0.002610419,"domain_scores_codex":[0.9929201,0.003945102,0.0008426613,0.0004686931,0.001528421,0.000294967],"domain_scores_gemma":[0.9844524,0.01223209,0.001415645,0.0004864655,0.001084098,0.000329289],"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":[0.001168571,0.0005628119,0.0121095,0.01466962,0.00048033,0.1796667,0.00702981,0.002308836,0.007172075,0.09160116,0.04267871,0.6405519],"study_design_scores_gemma":[0.0001629002,0.000681456,0.003142231,0.01421205,0.0008256622,0.2118035,0.003928793,0.001504975,0.007175024,0.02079975,0.7356358,0.0001278474],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.06522986,0.7778007,0.03111345,0.06333319,0.002800433,0.000750293,0.0003158984,0.0001274014,0.05852875],"genre_scores_gemma":[0.3911419,0.539757,0.02740714,0.02656289,0.002917286,0.0003067105,0.0003215156,0.0001480782,0.01143754],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.01254857,"threshold_uncertainty_score":0.06636393,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0740358983480155,"score_gpt":0.3811194096433451,"score_spread":0.3070835112953296,"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."}}