{"id":"W2045717403","doi":"10.1016/j.ejps.2011.09.010","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":"European Journal of Pharmaceutical Sciences","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":26,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada; Apotex (Canada); BioPhage Pharma (Canada)","funders":"","keywords":"Interchangeability; Harmonization; Bioequivalence; Regulatory science; Risk analysis (engineering); Business; Equivalence (formal languages); Pharmaceutical industry; Management science; Pharmacology; Computer science; Medicine; Economics; Pharmacokinetics; Mathematics","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":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.3764447,0.001549813,0.002834415,0.003222517,0.001562287,0.008750127,0.008386796,0.006939582,0.004132166],"category_scores_gemma":[0.1850558,0.001300498,0.00634925,0.002702092,0.004110858,0.004442677,0.00795488,0.007408096,0.001290707],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005544937,"about_ca_system_score_gemma":0.02374565,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003230833,"about_ca_topic_score_gemma":0.002971321,"domain_scores_codex":[0.7508914,0.1825987,0.01399754,0.00749522,0.04100333,0.004013747],"domain_scores_gemma":[0.7941253,0.1002047,0.01673266,0.02546302,0.05964846,0.003825967],"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":[0.01059414,0.003878744,0.007559373,0.0078772,0.003248715,0.0004773892,0.00552014,0.02640819,0.03278043,0.1033139,0.08451633,0.7138254],"study_design_scores_gemma":[0.00762611,0.0175348,0.05355925,0.009978349,0.004550927,0.001231314,0.004019076,0.0319031,0.1480978,0.1186341,0.6020663,0.0007986711],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"other","genre_scores_codex":[0.07798051,0.04316549,0.7080974,0.07259243,0.006030625,0.03064251,0.004832538,0.001170296,0.05548818],"genre_scores_gemma":[0.3360978,0.01386906,0.6016125,0.01459182,0.002110715,0.01460891,0.006481916,0.0008490752,0.009778156],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.3764447,"threshold_uncertainty_score":0.7689548,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8796313223735304,"score_gpt":0.5833190707002008,"score_spread":0.2963122516733295,"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."}}