{"id":"W3174856630","doi":"10.1186/s12902-021-00797-4","title":"Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies","year":2021,"lang":"en","type":"article","venue":"BMC Endocrine Disorders","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":4,"is_retracted":false,"has_abstract":true,"ca_institutions":"Altasciences (Canada)","funders":"Biocon","keywords":"Medicine; Insulin glargine; Immunogenicity; Diabetes mellitus; Internal medicine; Insulin; Gastroenterology; Endocrinology; Antibody; Type 2 diabetes; Immunology","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":[0.0004061568,0.0003557757,0.0005532026,0.00007957349,0.0003500047,0.00004377808,0.0002687076,0.0001220204,0.00003490051],"category_scores_gemma":[0.0008102895,0.0001830444,0.00006712338,0.0004512571,0.001151621,0.0001135251,0.0003554188,0.0005442081,0.000002772678],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00002691516,"about_ca_system_score_gemma":0.00009310665,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00004060746,"about_ca_topic_score_gemma":0.0003026276,"domain_scores_codex":[0.9977179,0.0006598022,0.0004641854,0.0005336034,0.00009754211,0.0005269679],"domain_scores_gemma":[0.9982306,0.001003466,0.0001497674,0.0004313423,0.0001473742,0.00003747408],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.0006862315,0.0006900285,0.9399878,0.0001914489,0.0008941609,0.000005524127,0.0004466128,0.000002742967,0.002719693,0.0003152446,0.0003203582,0.0537402],"study_design_scores_gemma":[0.02266965,0.001611094,0.8397311,0.0003041172,0.0007054365,0.00000904739,0.003924361,0.00003756835,0.09453224,0.001438486,0.03408318,0.0009537206],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9617092,0.03369345,0.00002692838,0.00349888,0.00009061229,0.0007033267,0.0001910266,0.00003274479,0.00005385339],"genre_scores_gemma":[0.9937839,0.004917547,0.0006244385,0.0004092387,0.00001822141,0.00005108935,0.0001218269,0.00002095165,0.00005281691],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1002567,"threshold_uncertainty_score":0.7464334,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02439025488742068,"score_gpt":0.2909738749663911,"score_spread":0.2665836200789704,"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."}}