{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.03016249,0.001628223,0.001573021,0.003171314,0.008802048,0.01676455,0.005474898,0.05458808,0.01817097],"category_scores_gemma":[0.04000309,0.000871756,0.003160267,0.003857422,0.01376478,0.006812857,0.004658122,0.02679239,0.002379684],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.08222409,"about_ca_system_score_gemma":0.4000431,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.8706622,"about_ca_topic_score_gemma":0.9070734,"domain_scores_codex":[0.9651853,0.006227269,0.001448608,0.002297469,0.0178292,0.007012188],"domain_scores_gemma":[0.9124854,0.01779922,0.002511688,0.001239514,0.04049156,0.02547259],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.0001429258,0.0001094641,0.001055909,0.0004863862,0.00006111273,0.0008670548,0.0003807434,0.0008891859,0.0007586952,0.108253,0.8481453,0.03885017],"study_design_scores_gemma":[0.000124142,0.0001221371,0.00204031,0.0008106948,0.00006052092,0.0004481678,0.0007408948,0.000640646,0.0002463318,0.02007462,0.9745657,0.0001257948],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"commentary","genre_scores_codex":[0.0003758352,0.01322301,0.0003613193,0.9683099,0.004682786,0.00002396981,0.0001519631,0.00003130573,0.01283989],"genre_scores_gemma":[0.02230379,0.0323737,0.003272908,0.9164972,0.008452927,0.00004562907,0.0002478013,0.00006000431,0.0167461],"genre_candidate":"commentary","genre_consensus":"commentary","teacher_disagreement_score":0.9698375,"threshold_uncertainty_score":0.5965804,"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."}}