{"id":"W2217300526","doi":"10.1016/j.semarthrit.2014.10.015","title":"Introduction and commentary: Biosimilars—clinical trial and safety considerations","year":2014,"lang":"en","type":"article","venue":"Seminars in Arthritis and Rheumatism","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":1,"is_retracted":false,"has_abstract":false,"ca_institutions":"McMaster University","funders":"","keywords":"Biosimilar; Medicine; Comparability; Risk analysis (engineering); Interchangeability; Clinical trial; Product (mathematics); Quality (philosophy); Pharmacovigilance; Drug development; Pharmacology; Drug; Computer science","routes":{"ca_aff":true,"ca_fund":false,"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":[0.03770583,0.002208861,0.005021295,0.00321161,0.005054372,0.008677984,0.009498629,0.116803,0.01025389],"category_scores_gemma":[0.1841207,0.002552156,0.005352663,0.00346948,0.01016083,0.007761762,0.004629349,0.09512386,0.009782837],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01389224,"about_ca_system_score_gemma":0.01610035,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00764912,"about_ca_topic_score_gemma":0.01161252,"domain_scores_codex":[0.9604856,0.01385097,0.007654518,0.004608906,0.01112729,0.002272643],"domain_scores_gemma":[0.7350962,0.1999738,0.01842731,0.003898965,0.0326278,0.009975878],"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":[0.0001051307,0.00001046936,0.0000539285,0.0004265276,0.00006113652,0.0001207586,0.00005996506,0.00004455103,0.0000781479,0.001269206,0.9939008,0.003869384],"study_design_scores_gemma":[0.0005224791,0.0001021559,0.0005797724,0.004206658,0.0005045916,0.0005105225,0.0002308299,0.0003469102,0.0003550164,0.01056285,0.9819519,0.0001262243],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"commentary","genre_scores_codex":[0.00009306386,0.004634378,0.0001339469,0.8478169,0.1463657,0.00002772038,0.0001163196,0.00002693764,0.0007848988],"genre_scores_gemma":[0.0006057331,0.001146495,0.0001554384,0.8888024,0.1083118,0.00003720545,0.00002174571,0.000021983,0.0008971269],"genre_candidate":"commentary","genre_consensus":"commentary","teacher_disagreement_score":0.116803,"threshold_uncertainty_score":0.1994099,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01902055445528217,"score_gpt":0.2992415445851379,"score_spread":0.2802209901298557,"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."}}