{"id":"W2903785850","doi":"10.1007/978-3-319-99680-6_6","title":"Clinical Information Requirements for Biosimilar Biologic Drug Approvals in Canada","year":2018,"lang":"en","type":"book-chapter","venue":"AAPS advances in the pharmaceutical sciences series","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"","keywords":"Biosimilar; Context (archaeology); Medicine; Drug; Pharmacology; Pharmacovigilance; Risk analysis (engineering); Internal medicine","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["sts"],"consensus_categories":[],"category_scores_codex":[0.00362527,0.0003474407,0.0005945354,0.0001243754,0.0002319233,0.00004440935,0.001091487,0.0003201377,0.0006749111],"category_scores_gemma":[0.0004381434,0.0002050887,0.0001430243,0.0001838943,0.002860691,0.0006078623,0.0002049113,0.0006560502,0.00003795963],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001719977,"about_ca_system_score_gemma":0.0004861301,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00269411,"about_ca_topic_score_gemma":0.1029149,"domain_scores_codex":[0.9972909,0.0003274248,0.001057111,0.0005085453,0.0001647149,0.0006512741],"domain_scores_gemma":[0.9980277,0.001252057,0.0003305708,0.0002639487,0.00008037642,0.00004536611],"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":[0.00320565,0.0004492041,0.01591333,0.0009781154,0.0004501728,0.00004403609,0.001740094,0.00005837615,0.0006727162,0.3065505,0.06868438,0.6012534],"study_design_scores_gemma":[0.000553133,0.0002909519,0.000108267,0.0001136864,0.00004784764,0.00001239323,0.000508279,0.00003998819,0.0008619349,0.04306496,0.9540821,0.0003164954],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.01126481,0.1569187,0.00143867,0.05567398,0.02993721,0.01261888,0.003144018,0.0002524442,0.7287512],"genre_scores_gemma":[0.4303885,0.2673985,0.04313665,0.12998,0.002883022,0.001433148,0.001244846,0.0002312503,0.1233041],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.8853977,"threshold_uncertainty_score":0.999853,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1056332647317857,"score_gpt":0.4099279671819406,"score_spread":0.3042947024501549,"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."}}