{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001255864,0.0009237134,0.001257054,0.0003702971,0.0003652858,0.0007252877,0.0004855338,0.001716907,0.001975459],"category_scores_gemma":[0.001972505,0.0006180916,0.000850242,0.0003351501,0.0009064884,0.0008692312,0.0002026851,0.001740441,0.0005580697],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0005397119,"about_ca_system_score_gemma":0.0005960384,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0006608763,"about_ca_topic_score_gemma":0.000452396,"domain_scores_codex":[0.9992642,0.0004027169,0.00003484637,0.000147047,0.00007502507,0.00007606423],"domain_scores_gemma":[0.9991376,0.0002279234,0.0001923738,0.000102805,0.00006722417,0.0002721242],"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":[0.9028744,0.016297,0.004110358,0.000250049,0.0005425896,0.0001034333,0.0001577451,0.0006229149,0.04232957,0.0001262864,0.0005014523,0.03208422],"study_design_scores_gemma":[0.2461562,0.6994954,0.0353162,0.00003433047,0.001470536,0.0004218516,0.00009874073,0.003175803,0.01225105,0.0002476423,0.001257705,0.00007453406],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.998275,0.0006832306,0.000287861,0.00004271122,0.00003587013,0.0001565432,0.0001586716,0.0000296703,0.0003305137],"genre_scores_gemma":[0.9979634,0.0003264796,0.00042028,0.0001656711,0.0001116678,0.0002013977,0.0002437354,0.00001195817,0.0005552964],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.001975459,"threshold_uncertainty_score":0.006641746,"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."}}