{"id":"W2094323797","doi":"10.1002/jcph.339","title":"Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation","year":2014,"lang":"en","type":"review","venue":"The Journal of Clinical Pharmacology","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":40,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Biosimilar; Monoclonal antibody; Perspective (graphical); Medicine; Extrapolation; Pharmacology; Antibody; Internal medicine; Immunology; Computer science; Mathematics; Statistics; Artificial intelligence","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":["research_integrity"],"consensus_categories":[],"category_scores_codex":[0.01332524,0.0003285408,0.002441965,0.0002467515,0.0002229131,0.00001174296,0.0007965656,0.000948249,0.000407197],"category_scores_gemma":[0.001889001,0.0001462632,0.0007355037,0.0001824271,0.001885649,0.00003560331,0.0001018111,0.002692779,0.000008153429],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001156852,"about_ca_system_score_gemma":0.001327522,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001364078,"about_ca_topic_score_gemma":0.0001192346,"domain_scores_codex":[0.9877328,0.008390196,0.00314307,0.0002888867,0.0001317902,0.0003132697],"domain_scores_gemma":[0.9777201,0.0175626,0.00392534,0.0003085807,0.0003568643,0.0001264582],"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":[0.001684345,0.00128019,0.004279201,0.001667734,0.011937,0.00002325239,0.0004307471,0.000002746513,0.0003511398,0.01599074,0.04827451,0.9140784],"study_design_scores_gemma":[0.001604466,0.003966703,0.02054929,0.002416019,0.007981744,0.0002564258,0.0002420722,0.00005786967,0.00003661818,0.002702056,0.9597843,0.000402412],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.005482782,0.978188,0.0001460702,0.01144987,0.003035783,0.0007895792,0.00008242099,0.000007348765,0.0008180917],"genre_scores_gemma":[0.03472578,0.9624822,0.000297894,0.001894355,0.0004936846,0.000005807334,0.000003964857,0.00001841456,0.0000779367],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.913676,"threshold_uncertainty_score":0.999608,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1412695353166486,"score_gpt":0.5070305994950575,"score_spread":0.3657610641784089,"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."}}