{"id":"W4379648580","doi":"10.1136/annrheumdis-2023-eular.268","title":"AB0402 PHARMACOKINETICS AND SAFETY OF CT-P47, A PROPOSED TOCILIZUMAB BIOSIMILAR, IN COMPARISON WITH EU-APPROVED TOCILIZUMAB; A PHASE 1, RANDOMIZED, DOUBLE-BLIND, TWO-ARM, SINGLE-DOSE STUDY IN HEALTHY SUBJECTS","year":2023,"lang":"en","type":"article","venue":"Annals of the Rheumatic Diseases","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":1,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of Toronto","funders":"Pfizer Pharmaceuticals; Sanofi Genzyme; Biogen; Gilead Sciences; Chugai Pharmaceutical; Celltrion; Sanofi; Amgen; Pfizer; Samsung; AstraZeneca; Eli Lilly and Company","keywords":"Medicine; Tocilizumab; Pharmacokinetics; Bioequivalence; Clinical endpoint; Area under the curve; Internal medicine; Pharmacodynamics; Nuclear medicine; Gastroenterology; Urology; Pharmacology; Randomized controlled trial; 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":[],"consensus_categories":[],"category_scores_codex":[0.00168744,0.0003712586,0.001675857,0.000336761,0.0001046866,0.00002296713,0.0004292222,0.00009785858,0.00008553456],"category_scores_gemma":[0.0005970944,0.0002280833,0.0002375845,0.001112602,0.0009082119,0.00008977905,0.000242661,0.0003172196,0.000003849905],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00003117669,"about_ca_system_score_gemma":0.0001900563,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004629023,"about_ca_topic_score_gemma":0.0005010206,"domain_scores_codex":[0.995724,0.001640579,0.001415688,0.0004699405,0.0001978327,0.0005520117],"domain_scores_gemma":[0.997241,0.001390334,0.0006076118,0.0005172106,0.0001535389,0.000090355],"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":[0.9350731,0.01647999,0.009505795,0.001179873,0.001481322,0.00003079639,0.002600789,0.0001935662,0.002491414,0.0004004563,0.001087909,0.02947493],"study_design_scores_gemma":[0.9526799,0.004664158,0.008284301,0.001558169,0.0009093005,0.0000194445,0.003575734,0.002487415,0.0238552,0.001186365,0.0001626197,0.0006174094],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9879575,0.004214126,0.00002388321,0.002774358,0.0001583115,0.004519562,0.0001348794,0.00004548232,0.0001719117],"genre_scores_gemma":[0.998673,0.0006329603,0.0001186374,0.0003004622,0.000006649049,0.0001420199,0.00002813998,0.00002569175,0.00007250216],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.02885753,"threshold_uncertainty_score":0.9300966,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1011446418855259,"score_gpt":0.3942498664126933,"score_spread":0.2931052245271674,"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."}}