{"id":"W2097775534","doi":"10.1208/s12248-011-9294-5","title":"Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report","year":2011,"lang":"en","type":"article","venue":"The AAPS Journal","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":17,"is_retracted":false,"has_abstract":false,"ca_institutions":"Apotex (Canada); Health Canada","funders":"","keywords":"Interchangeability; Harmonization; Bioequivalence; Regulatory science; Risk analysis (engineering); Regulatory authority; Business; Equivalence (formal languages); Biosimilar; Pharmaceutical industry; Pharmacology; Management science; Computer science; Medicine; Biotechnology; Engineering; Political science; Biology; Mathematics; 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":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.02030801,0.0001230365,0.0004426581,0.00004372757,0.00009737642,0.00001317516,0.0002959892,0.00006699075,0.00003380279],"category_scores_gemma":[0.08333234,0.00007782904,0.00009712105,0.0001341741,0.000481496,0.00008110269,0.0001236334,0.0002757703,1.579095e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00002771942,"about_ca_system_score_gemma":0.00006538998,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000003288474,"about_ca_topic_score_gemma":5.717429e-7,"domain_scores_codex":[0.9967359,0.001310007,0.00121394,0.0002198677,0.0003487055,0.0001716206],"domain_scores_gemma":[0.981092,0.01640623,0.001389819,0.0005549144,0.0004985346,0.00005853136],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.003780054,0.00168489,0.01230972,0.004417419,0.001076927,0.00001512505,0.05345623,0.00004743648,0.0208399,0.04635656,0.0009636186,0.8550521],"study_design_scores_gemma":[0.0006938328,0.0002071746,0.004491323,0.0004346646,0.0003378559,0.0001145559,0.001591481,0.003271195,0.02136258,0.9673662,0.000007725647,0.0001214213],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.4978264,0.0006997905,0.4996531,0.0003851266,0.0003268399,0.0009371,0.0000127475,0.00001740885,0.0001415162],"genre_scores_gemma":[0.5099964,0.00003139724,0.4897371,0.0000126201,0.0001028858,0.0000140754,2.805501e-7,0.00001622166,0.00008894654],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.9210097,"threshold_uncertainty_score":0.9243891,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8440144888399592,"score_gpt":0.5456233684349235,"score_spread":0.2983911204050357,"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."}}