{"id":"W2014423310","doi":"10.1002/sim.5569","title":"On the interchangeability of biologic drug products","year":2012,"lang":"en","type":"article","venue":"Statistics in Medicine","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":22,"is_retracted":false,"has_abstract":true,"ca_institutions":"Canada Research Chairs; University of Toronto","funders":"","keywords":"Interchangeability; Bioequivalence; Drug; Risk analysis (engineering); Biosimilar; Tilmicosin; Medicine; Equivalence (formal languages); Pharmacology; Computer science; Mathematics; Chemistry; Pharmacokinetics","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":"codex-gemma-dda1882f352a","candidate_categories":["insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.001963177,0.00008494389,0.0002279202,0.00004726886,0.0000272239,5.975754e-7,0.0001387425,0.00007193337,0.001285077],"category_scores_gemma":[0.00450298,0.00003942324,0.00001280571,0.0001508242,0.0008451598,0.000008955562,0.00004434779,0.000271733,0.00002436172],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00001764757,"about_ca_system_score_gemma":0.000009972572,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00006136279,"about_ca_topic_score_gemma":0.00002834977,"domain_scores_codex":[0.9989577,0.0004339858,0.0002435014,0.0001198118,0.00003254873,0.0002124758],"domain_scores_gemma":[0.9978645,0.00176776,0.00006966521,0.0002292051,0.00005525791,0.00001363684],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"observational","study_design_scores_codex":[0.000305597,0.0006350055,0.04948092,0.0001584504,0.000114951,0.000002822059,0.00285314,2.467433e-7,0.0706361,0.6865259,0.1600039,0.0292829],"study_design_scores_gemma":[0.002990299,0.002810057,0.5509533,0.0005923295,0.0002499402,0.00002998916,0.003078138,0.00002926516,0.1475122,0.2083628,0.08280278,0.0005889315],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.916323,0.009970704,0.01076107,0.04144058,0.006732062,0.001417676,0.0006009914,0.00005770966,0.01269618],"genre_scores_gemma":[0.9960617,0.0000689943,0.002546742,0.0007716276,0.00005674808,0.00000682694,0.00001732653,0.000003655133,0.0004664062],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5014724,"threshold_uncertainty_score":0.9996279,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06153093761929549,"score_gpt":0.3525918014453326,"score_spread":0.2910608638260371,"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."}}