{"id":"W4378347895","doi":"10.1080/13543784.2023.2212155","title":"Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study","year":2023,"lang":"en","type":"article","venue":"Expert Opinion on Investigational Drugs","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":12,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto","funders":"Celltrion","keywords":"Tocilizumab; Medicine; Bioequivalence; Clinical endpoint; Cmax; Pharmacokinetics; Adverse effect; Internal medicine; Confidence interval; Pharmacology; Randomized controlled trial; European union; Area under the curve; Rheumatoid arthritis; Gastroenterology","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":[0.001103218,0.0003612627,0.0007388143,0.0002872217,0.0002640371,0.00003157349,0.0002849498,0.0001878562,0.0004711761],"category_scores_gemma":[0.0004420239,0.0002908977,0.0001537183,0.0005472699,0.001120433,0.0001063532,0.0001871096,0.0003843375,0.00007378054],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00007813454,"about_ca_system_score_gemma":0.000155838,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001474925,"about_ca_topic_score_gemma":0.000007716559,"domain_scores_codex":[0.9971442,0.0007680795,0.0008337185,0.0006163443,0.0002390588,0.0003985739],"domain_scores_gemma":[0.9975952,0.001463035,0.0002707266,0.0003521128,0.0001890009,0.0001299288],"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":[0.8380491,0.002554988,0.0001002409,0.00008500206,0.001688135,0.00001972321,0.004639823,0.00005617631,0.06580675,0.03121118,0.02840397,0.02738496],"study_design_scores_gemma":[0.820206,0.002203794,0.0001751862,0.0001759269,0.0001004786,0.00001640464,0.00163281,0.0005878526,0.08821864,0.001275229,0.084756,0.0006516436],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9388909,0.01035301,0.0002777956,0.02342641,0.008124186,0.007672591,0.00129491,0.0006337147,0.009326501],"genre_scores_gemma":[0.9949911,0.001903142,0.000603562,0.0008583356,0.0001363261,0.0002611595,0.0006416105,0.0000341703,0.0005705427],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.05635204,"threshold_uncertainty_score":0.9999543,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1185461092162821,"score_gpt":0.3922976279886577,"score_spread":0.2737515187723757,"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."}}