{"id":"W2907973703","doi":"10.18433/jpps30215","title":"A Survey of the Regulatory Requirements for the Acceptance of Foreign Comparator Products by Participating Regulators and Organizations of the International Generic Drug Regulators Programme","year":2019,"lang":"en","type":"article","venue":"Journal of Pharmacy & Pharmaceutical Sciences","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":10,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Bioequivalence; European union; Product (mathematics); Jurisdiction; Business; Medicine; Public economics; International trade; Pharmacology; Political science; Economics; Law","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":true,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.003516099,0.0001465822,0.0004089188,0.00008552361,0.0001879647,0.00005292707,0.001216928,0.00002928817,0.0001518302],"category_scores_gemma":[0.0007005758,0.00008774637,0.0001452543,0.0008964635,0.0008316278,0.0003317049,0.0002348096,0.0001885588,0.000001425058],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00006913023,"about_ca_system_score_gemma":0.0002227017,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00007560927,"about_ca_topic_score_gemma":0.000008912252,"domain_scores_codex":[0.9978232,0.00009963429,0.001289461,0.0002453221,0.0002348531,0.0003075511],"domain_scores_gemma":[0.997075,0.0004194783,0.001770283,0.0002454093,0.0003746264,0.0001151667],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.0001069611,0.0002384636,0.9529338,0.0001123907,0.0002321098,6.637095e-8,0.000472,0.001062044,0.01531869,0.02223664,0.004389668,0.002897108],"study_design_scores_gemma":[0.004357212,0.0001647301,0.3831256,0.0001338061,0.0002034213,0.00001682652,0.0003423428,0.1502861,0.370756,0.004686643,0.08549332,0.0004339748],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9911091,0.002998883,0.00006253456,0.003888551,0.0009222753,0.0005759382,0.000168813,0.00000292278,0.0002710252],"genre_scores_gemma":[0.9988545,0.0002672343,0.0001956183,0.000498202,0.00009267255,0.00001076003,0.000001107998,0.00001311839,0.00006678159],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5698082,"threshold_uncertainty_score":0.3578193,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1634503946153324,"score_gpt":0.3704488296778767,"score_spread":0.2069984350625443,"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."}}