{"id":"W2326320320","doi":"10.5639/gabij.2015.0401.009","title":"Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges","year":2015,"lang":"en","type":"article","venue":"Generics and Biosimilars Initiative Journal","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":6,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Biosimilar; Perspective (graphical); Regulatory science; Business; Medicine; Computer science; Internal medicine; Pathology","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":[],"consensus_categories":[],"category_scores_codex":[0.003841761,0.0002251521,0.0004744995,0.0001205761,0.0006811041,0.00005021179,0.0001520184,0.0002146977,0.00002230054],"category_scores_gemma":[0.000441336,0.0001370557,0.00005545229,0.0001632987,0.001300766,0.00005562075,0.0001615077,0.0006141852,6.336227e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001462101,"about_ca_system_score_gemma":0.001627015,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00003707498,"about_ca_topic_score_gemma":0.004020132,"domain_scores_codex":[0.9975895,0.0008438134,0.000675603,0.0003932073,0.000155108,0.0003427968],"domain_scores_gemma":[0.9984403,0.0003775905,0.0004390191,0.000173024,0.0003715943,0.000198495],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0006465577,0.0006012478,0.008279542,0.00009651573,0.002141082,0.00005477857,0.01402804,0.000002152022,0.004216735,0.007394871,0.8541213,0.1084172],"study_design_scores_gemma":[0.007781723,0.004963475,0.3357602,0.0008513947,0.0004097214,0.001835141,0.0662488,0.0001075108,0.03054469,0.02376398,0.5260041,0.00172919],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.3654431,0.1441589,0.0001114705,0.4831046,0.003090831,0.0005922237,0.0001446586,0.00002719866,0.003326996],"genre_scores_gemma":[0.9533316,0.01263697,0.003711745,0.03009352,0.00008731461,0.000005166627,0.000007694051,0.00002815295,0.000097845],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.5878885,"threshold_uncertainty_score":0.5588967,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1566998178822719,"score_gpt":0.3526119372573578,"score_spread":0.1959121193750858,"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."}}