{"id":"W2133707942","doi":"10.1002/sim.5567","title":"Impact of variability on the choice of biosimilarity limits in assessing follow‐on biologics","year":2012,"lang":"en","type":"article","venue":"Statistics in Medicine","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":12,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto","funders":"","keywords":"Biosimilar; Bioequivalence; Econometrics; Limit (mathematics); Statistics; Computer science; Economics; Mathematics; Pharmacology; Medicine; Biotechnology; Biology","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":[0.04763254,0.0007525269,0.0009441655,0.001259523,0.000465684,0.002474685,0.001230352,0.001522261,0.0005631241],"category_scores_gemma":[0.166245,0.000308118,0.001322699,0.001155439,0.00191783,0.002360568,0.001983087,0.0019276,0.0001647235],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0007271525,"about_ca_system_score_gemma":0.0008033174,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0005218705,"about_ca_topic_score_gemma":0.0003147784,"domain_scores_codex":[0.957593,0.02732181,0.00266305,0.002706385,0.009168166,0.0005476642],"domain_scores_gemma":[0.7457767,0.2200003,0.01185099,0.01394878,0.007808896,0.0006143315],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"simulation_or_modeling","study_design_gemma":"simulation_or_modeling","study_design_scores_codex":[0.003434338,0.0006390692,0.08903258,0.0007665143,0.001330916,0.00120867,0.001141908,0.4054694,0.05582057,0.08005542,0.002015552,0.359085],"study_design_scores_gemma":[0.0002421523,0.001984572,0.06746147,0.0004763437,0.0005358378,0.001720813,0.0003919787,0.691277,0.08965103,0.140281,0.005545213,0.0004326269],"study_design_candidate":"simulation_or_modeling","study_design_consensus":"simulation_or_modeling","genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.2791314,0.002034916,0.7115012,0.00100024,0.0001298121,0.0001779067,0.0001616358,0.0003522127,0.005510687],"genre_scores_gemma":[0.9001717,0.0002443483,0.09876706,0.000213299,0.00006234949,0.0001062135,0.000116886,0.00009549543,0.0002226531],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.04763254,"threshold_uncertainty_score":0.251908,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.09628629694275934,"score_gpt":0.4257078071314531,"score_spread":0.3294215101886937,"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."}}