{"id":"W1997256514","doi":"10.1002/sim.5572","title":"Comments on the FDA draft guidance on biosimilar products","year":2012,"lang":"en","type":"article","venue":"Statistics in Medicine","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":14,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto","funders":"","keywords":"Interchangeability; Biosimilar; Food and drug administration; Risk analysis (engineering); Computer science; Scientific evidence; Management science; Operations research; Business; Medicine; Engineering; Statistics","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":[0.00138763,0.0001673509,0.0002676287,0.00007071803,0.0001105637,0.000003607718,0.0002217599,0.0001258678,0.00111325],"category_scores_gemma":[0.002313348,0.00008868331,0.00001604537,0.0002016247,0.0005309199,0.00001681701,0.00004628768,0.0004825779,0.0001928798],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00004279687,"about_ca_system_score_gemma":0.00001511333,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00001965346,"about_ca_topic_score_gemma":0.000006805974,"domain_scores_codex":[0.9985976,0.0003993735,0.0002966531,0.0002079937,0.00008565185,0.000412683],"domain_scores_gemma":[0.9982163,0.001234724,0.00008318775,0.0003788121,0.00005333646,0.00003364727],"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":[0.0001744978,0.0004064062,0.005972241,0.00003685733,0.00008801292,0.000009326332,0.0004753926,5.62123e-7,0.01377868,0.1699414,0.7977748,0.01134189],"study_design_scores_gemma":[0.002134203,0.001518454,0.07288233,0.0004551043,0.0001094226,0.00001526677,0.000367895,0.00002228575,0.03974036,0.00732999,0.8750623,0.0003623716],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.08312262,0.0266742,0.01958995,0.6809264,0.03233122,0.00495091,0.002311981,0.0003386075,0.1497542],"genre_scores_gemma":[0.9589822,0.0002848642,0.006378428,0.03034227,0.0003917415,0.00002877024,0.00007301552,0.00002496181,0.003493744],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.8758596,"threshold_uncertainty_score":0.9997998,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0515523949308303,"score_gpt":0.3530185489860644,"score_spread":0.3014661540552341,"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."}}