{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.001446608,0.0005111237,0.001920061,0.0003471704,0.0001211407,0.00006301593,0.0003857759,0.0001653544,0.0001029403],"category_scores_gemma":[0.0004453298,0.000316407,0.0002383057,0.0007812502,0.001299242,0.000136519,0.0002355835,0.0004708669,0.000001842719],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00005497216,"about_ca_system_score_gemma":0.0002714234,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001130572,"about_ca_topic_score_gemma":0.001574322,"domain_scores_codex":[0.9956321,0.001316321,0.001551256,0.0006709275,0.0002285011,0.0006008873],"domain_scores_gemma":[0.9971659,0.00155388,0.0004520073,0.0005363098,0.0001648042,0.0001271421],"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":[0.8933268,0.01588372,0.003779429,0.003452692,0.002394248,0.0000790324,0.007599605,0.00006453769,0.00271996,0.0004207433,0.0003537562,0.06992552],"study_design_scores_gemma":[0.9360204,0.01234684,0.01149355,0.004979665,0.002525788,0.0001755641,0.006358234,0.006996774,0.01586637,0.001628865,0.0003130951,0.001294896],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9680022,0.0237957,0.00003187897,0.00217383,0.0001839552,0.005439066,0.0001762083,0.00004694666,0.0001502044],"genre_scores_gemma":[0.9982437,0.001077325,0.0001370772,0.0002761255,0.00001016466,0.0001535389,0.00002203693,0.00003674846,0.0000433097],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.06863062,"threshold_uncertainty_score":0.9999288,"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."}}