{"id":"W3124773781","doi":"10.1111/cts.12967","title":"Pharmacokinetic equivalence of CT‐P17 to high‐concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects","year":2021,"lang":"en","type":"article","venue":"Clinical and Translational Science","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto; Mount Sinai Hospital","funders":"Celltrion","keywords":"Adalimumab; Medicine; Pharmacokinetics; Biosimilar; Equivalence (formal languages); European union; Internal medicine; Randomized controlled trial; Pharmacology; Gastroenterology; Mathematics","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":[0.004279245,0.001352764,0.002594758,0.0003933839,0.0005523147,0.00070662,0.0007012272,0.001116269,0.003769605],"category_scores_gemma":[0.002914805,0.0007317338,0.001067231,0.0004930501,0.001758816,0.001019282,0.0004074408,0.002473788,0.0008070685],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0006991546,"about_ca_system_score_gemma":0.001853207,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0003868402,"about_ca_topic_score_gemma":0.0004079997,"domain_scores_codex":[0.9983528,0.0009012154,0.0001103896,0.0002813445,0.0002060884,0.0001480901],"domain_scores_gemma":[0.9987207,0.0002864884,0.0003042806,0.0002197769,0.0001363801,0.0003322585],"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":[0.8891822,0.05402709,0.001436078,0.0003986793,0.0004453266,0.0001045399,0.0001529871,0.0007603935,0.03064887,0.000239328,0.0008766848,0.02172784],"study_design_scores_gemma":[0.314098,0.6740302,0.002936994,0.00002100286,0.0004103841,0.0001353538,0.00004179006,0.001123977,0.005482338,0.000182394,0.001509775,0.00002765301],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9901287,0.0008182158,0.002143864,0.0001127599,0.0002192263,0.005476435,0.0003696125,0.00006833845,0.0006629126],"genre_scores_gemma":[0.9880489,0.0006056048,0.003077165,0.0003612226,0.0003213927,0.006033511,0.0003882213,0.00002717017,0.001136828],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.004279245,"threshold_uncertainty_score":0.02263105,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1132305265390118,"score_gpt":0.460960455324095,"score_spread":0.3477299287850831,"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."}}