{"id":"W1980282196","doi":"10.1016/j.biologicals.2014.05.005","title":"The challenge of indication extrapolation for infliximab biosimilars","year":2014,"lang":"en","type":"review","venue":"Biologicals","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":148,"is_retracted":false,"has_abstract":true,"ca_institutions":"Western University; University of British Columbia; University of Toronto; University of Calgary; University of Alberta; Robarts Clinical Trials; Université de Montréal","funders":"Genentech; Celltrion; UCB; LEO Pharma; Ironwood Pharmaceuticals, Incorporated; Teva Pharmaceutical Industries; Gilead Sciences; ActoGeniX; Sanofi; Celgene; Biogen; GlaxoSmithKline; Amgen; Pfizer; AstraZeneca; Eli Lilly and Company; Bristol-Myers Squibb","keywords":"Biosimilar; Infliximab; Medicine; Extrapolation; Pharmacology; Internal medicine; Mathematics; Tumor necrosis factor alpha; Statistics","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"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":[0.0112597,0.0005842834,0.001735351,0.002362078,0.0006040737,0.002747276,0.001789489,0.003818176,0.002394384],"category_scores_gemma":[0.01266332,0.0004270155,0.001508366,0.001878235,0.002269245,0.004954778,0.001465213,0.007064414,0.00156899],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001873269,"about_ca_system_score_gemma":0.004940892,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001378643,"about_ca_topic_score_gemma":0.001753541,"domain_scores_codex":[0.9942744,0.002068339,0.0009367411,0.0003902493,0.002189843,0.0001404062],"domain_scores_gemma":[0.987049,0.009411496,0.001233807,0.0003552666,0.001760143,0.0001902234],"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":[0.00006946558,0.00005112106,0.0002853978,0.01528529,0.00007295331,0.0007145735,0.0005807158,0.0005052132,0.001381481,0.04439732,0.03048319,0.9061732],"study_design_scores_gemma":[0.00002232528,0.00008025816,0.000431547,0.009910886,0.00007948207,0.002810037,0.0003179568,0.0001727607,0.0005544426,0.0117494,0.9738451,0.00002579394],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.000524615,0.9849182,0.001927924,0.007247344,0.0008382876,0.00003721967,0.00002608429,0.00002519031,0.00445513],"genre_scores_gemma":[0.006579083,0.979919,0.003776582,0.007011701,0.001088908,0.00006400452,0.00007128469,0.00001858411,0.001470904],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.0112597,"threshold_uncertainty_score":0.05954772,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1216315824002214,"score_gpt":0.4075227525799325,"score_spread":0.2858911701797111,"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."}}