{"id":"W2883638496","doi":"10.22270/ijdra.v3i4.172","title":"DMF FILING IN US, EUROPE AND CANADA","year":2018,"lang":"en","type":"article","venue":"International Journal of Drug Regulatory Affairs","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Confidentiality; Drug; Discretion; Business; Product (mathematics); Process (computing); Computer science; Internet privacy; Database; Law; Computer security; Political science; Pharmacology; Medicine; Operating system","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.000438628,0.00007305105,0.0001481347,0.0001733645,0.00002561177,0.00001588869,0.0001174161,0.00005656818,0.00007938111],"category_scores_gemma":[0.0001040135,0.00005693087,0.00003554922,0.00008482868,0.0003117636,0.00009114233,0.00003917269,0.0002468074,0.000001302148],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001485607,"about_ca_system_score_gemma":0.0006181601,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.008244515,"about_ca_topic_score_gemma":0.05413344,"domain_scores_codex":[0.9987276,0.00003318303,0.0003763543,0.00009581374,0.0006683364,0.00009876868],"domain_scores_gemma":[0.9990715,0.00005018296,0.0001873101,0.00007086429,0.0004828802,0.0001372768],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.00436393,0.001202843,0.5695626,0.0003989764,0.002511025,0.006797065,0.008402244,0.0004881751,0.06214268,0.04034495,0.0834521,0.2203335],"study_design_scores_gemma":[0.003738974,0.0002395133,0.8788859,0.001044833,0.00006411727,0.001632164,0.001087667,0.001956556,0.005771492,0.001532794,0.1038277,0.0002182869],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9828043,0.0003052848,0.00004332032,0.01361164,0.001244105,0.00004281869,0.000003362511,0.000004256938,0.001940928],"genre_scores_gemma":[0.9978514,0.0000758618,0.0003930112,0.000466421,0.0008369979,2.439851e-7,0.00000343652,0.000009183442,0.0003634715],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3093234,"threshold_uncertainty_score":0.9983597,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.007224715325814822,"score_gpt":0.2572803179572266,"score_spread":0.2500556026314117,"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."}}