{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.006532326,0.0004724271,0.0008682759,0.0002393904,0.0002487793,0.0006365919,0.0003695988,0.0006518768,0.001730233],"category_scores_gemma":[0.004194017,0.0002605052,0.001243636,0.0002636281,0.0004184493,0.0007755477,0.0003486362,0.001166108,0.0002212351],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0006340835,"about_ca_system_score_gemma":0.0007493407,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001872581,"about_ca_topic_score_gemma":0.0003754937,"domain_scores_codex":[0.9980351,0.001232989,0.0001791872,0.0001876881,0.0002396027,0.0001253785],"domain_scores_gemma":[0.9966487,0.001308279,0.0008913386,0.0003929128,0.0003060919,0.0004526835],"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":[0.6330273,0.02969669,0.1345364,0.0006836469,0.003279182,0.0003060415,0.0009379196,0.002110667,0.03615124,0.0005843241,0.00256097,0.1561257],"study_design_scores_gemma":[0.1331021,0.6672531,0.1821663,0.00009221247,0.001782247,0.0009219809,0.0002058089,0.001901522,0.007575854,0.0003519409,0.004569539,0.00007732744],"study_design_candidate":"randomized_trial","study_design_consensus":"randomized_trial","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9975227,0.0008932158,0.0003027885,0.00009187347,0.0000208581,0.0002827156,0.0001518927,0.000009050988,0.000724875],"genre_scores_gemma":[0.9977902,0.0003211155,0.0005130531,0.000312906,0.00005308616,0.000273141,0.0005149186,0.000005375838,0.0002162673],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.006532326,"threshold_uncertainty_score":0.03454667,"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."}}