{"id":"W4399484120","doi":"10.1136/annrheumdis-2024-eular.209","title":"AB0027 PHARMACOKINETICS AND SAFETY OF CT-P47, A PROPOSED TOCILIZUMAB BIOSIMILAR, IN COMPARISON WITH INTRAVENOUS EU-APPROVED TOCILIZUMAB AND US-LICENSED TOCILIZUMAB; A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THREE-ARM, SINGLE-DOSE STUDY IN HEALTHY JAPANESE SUBJECTS","year":2024,"lang":"en","type":"article","venue":"Annals of the Rheumatic Diseases","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of Toronto","funders":"","keywords":"Tocilizumab; Biosimilar; Medicine; Pharmacokinetics; Pharmacology; Internal medicine; Rheumatoid arthritis","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":[0.000844059,0.000834312,0.001080002,0.0002853391,0.0004024129,0.0005306895,0.0003145297,0.001099806,0.001289199],"category_scores_gemma":[0.001104268,0.0005342545,0.0007144902,0.0002779901,0.000890923,0.0007332049,0.0001881593,0.001452911,0.0003332464],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0004330177,"about_ca_system_score_gemma":0.0006220422,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00097712,"about_ca_topic_score_gemma":0.0007419034,"domain_scores_codex":[0.9996118,0.0001761202,0.00001821393,0.00009960403,0.00005002004,0.00004426588],"domain_scores_gemma":[0.9994901,0.00009968378,0.0001103972,0.00005107116,0.00004782005,0.0002007982],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.8281132,0.02263347,0.0128247,0.000489696,0.0009501111,0.000200815,0.0003983033,0.0007031198,0.09776929,0.0001439718,0.0005634759,0.03520989],"study_design_scores_gemma":[0.1676388,0.7068444,0.09413685,0.00004263948,0.003038853,0.0005511183,0.000231049,0.003923257,0.0212687,0.0002471818,0.001966667,0.0001105485],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9988702,0.0004719237,0.0001909016,0.00002210238,0.00002000838,0.0001083864,0.00007890732,0.0000139844,0.0002234479],"genre_scores_gemma":[0.9985229,0.0002585277,0.0003091033,0.0001104897,0.00005881191,0.0001414533,0.0001694645,0.000007979559,0.0004213155],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.001289199,"threshold_uncertainty_score":0.004463851,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06634039404615578,"score_gpt":0.3588344116626497,"score_spread":0.292494017616494,"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."}}