{"id":"W4403498878","doi":"10.1002/jcph.6139","title":"Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT‐P47 and Reference Tocilizumab: A Randomized, Double‐Blind, Phase 1 Study","year":2024,"lang":"en","type":"article","venue":"The Journal of Clinical Pharmacology","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto","funders":"Celltrion","keywords":"Tocilizumab; Medicine; Adverse effect; Internal medicine; Pharmacokinetics; Randomized controlled trial; Bioequivalence; Clinical endpoint; Area under the curve; Confidence interval; Pharmacodynamics; Gastroenterology; Pharmacology; 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":[0.002173785,0.001210089,0.002385268,0.0003784182,0.0004544831,0.0006415594,0.0007251111,0.001280502,0.002447248],"category_scores_gemma":[0.002576299,0.0007570263,0.0009322712,0.0004621529,0.001278541,0.0009743891,0.0002499305,0.001926526,0.0005000474],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0008896214,"about_ca_system_score_gemma":0.001673447,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004906101,"about_ca_topic_score_gemma":0.0005475818,"domain_scores_codex":[0.9987973,0.0006214783,0.00007174483,0.000202576,0.0001773965,0.0001294753],"domain_scores_gemma":[0.9986003,0.0002863662,0.0004920209,0.000165302,0.0001272482,0.0003287472],"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":[0.9002799,0.04493766,0.00148565,0.0004481184,0.000448476,0.00006435813,0.0001386903,0.0006747888,0.02569927,0.0001315218,0.0005890846,0.02510254],"study_design_scores_gemma":[0.4623535,0.5213923,0.005732242,0.00002712418,0.000713716,0.0001443063,0.00003848775,0.001601642,0.006732363,0.000127074,0.001096631,0.0000406039],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9950381,0.0006322587,0.00110251,0.00006613139,0.00006914982,0.00237126,0.0002717074,0.00004221629,0.0004067007],"genre_scores_gemma":[0.9918835,0.0006623743,0.002103849,0.0002720565,0.0002150472,0.003821146,0.0003741405,0.00002095211,0.0006468687],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.002447248,"threshold_uncertainty_score":0.01149619,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.09548188791577344,"score_gpt":0.4630843294698259,"score_spread":0.3676024415540525,"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."}}