{"id":"W2217300526","doi":"10.1016/j.semarthrit.2014.10.015","title":"Introduction and commentary: Biosimilars—clinical trial and safety considerations","year":2014,"lang":"en","type":"article","venue":"Seminars in Arthritis and Rheumatism","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":1,"is_retracted":false,"has_abstract":false,"ca_institutions":"McMaster University","funders":"","keywords":"Biosimilar; Medicine; Comparability; Risk analysis (engineering); Interchangeability; Clinical trial; Product (mathematics); Quality (philosophy); Pharmacovigilance; Drug development; Pharmacology; Drug; Computer science","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":[0.001351977,0.0001392299,0.0003922342,0.00006764309,0.000229152,0.00003767782,0.000032292,0.0002592431,0.0002702603],"category_scores_gemma":[0.0004729522,0.0001190991,0.00003253813,0.00005266725,0.0006975924,0.00008040371,0.0000901364,0.0003031179,0.000003736609],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000007295253,"about_ca_system_score_gemma":0.000008318041,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00003149253,"about_ca_topic_score_gemma":0.000121845,"domain_scores_codex":[0.9983903,0.00053762,0.0004987727,0.0003509832,0.00002614735,0.0001961591],"domain_scores_gemma":[0.9989829,0.0007291114,0.00007985606,0.0001432629,0.00001842538,0.00004643765],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0008377734,0.000118221,0.004887987,0.0000134732,0.00004853876,0.000002753742,0.0001715708,1.029309e-7,0.0008170453,0.008193011,0.06720085,0.9177087],"study_design_scores_gemma":[0.1814331,0.007446492,0.1696131,0.006434917,0.0002219523,0.002004911,0.001226966,0.0005323251,0.004068671,0.06352639,0.5616319,0.001859194],"study_design_candidate":"design_other","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8323743,0.1050233,0.0003332439,0.05900054,0.001922288,0.0006159278,0.00006180839,0.00004637765,0.0006222498],"genre_scores_gemma":[0.7058411,0.2852728,0.005386635,0.003134952,0.0001502375,0.00001441912,0.00002987883,0.00001117545,0.000158844],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.9158494,"threshold_uncertainty_score":0.4856722,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01902055445528217,"score_gpt":0.2992415445851379,"score_spread":0.2802209901298557,"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."}}