{"id":"W4296654249","doi":"10.23880/pdraj-16000108","title":"Filing of DMF in US, Canada &amp; Europe","year":2019,"lang":"en","type":"article","venue":"Pharmaceutical Drug Regulatory Affairs Journal","topic":"Pharmaceutical Quality and Counterfeiting","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Confidentiality; License; Quality (philosophy); Product (mathematics); Business; Computer science; Database; Law; Political science; Computer security; Mathematics","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.004143219,0.0005656856,0.0005960066,0.008089712,0.005160445,0.005694176,0.001598345,0.001622497,0.04974824],"category_scores_gemma":[0.01312909,0.0004194,0.0006595121,0.006839792,0.001683649,0.001599812,0.002041295,0.001503146,0.0224899],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01611434,"about_ca_system_score_gemma":0.05372631,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.6331334,"about_ca_topic_score_gemma":0.5965289,"domain_scores_codex":[0.9916493,0.0002823909,0.0004018424,0.0005630614,0.006036585,0.001066868],"domain_scores_gemma":[0.9865232,0.0008230164,0.0006878846,0.0008808848,0.01044922,0.0006357513],"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":[0.0002288573,0.000101606,0.0086361,0.0006595124,0.00003164727,0.001088327,0.001253766,0.0004507782,0.006746861,0.04766709,0.6310695,0.3020658],"study_design_scores_gemma":[0.000008258767,0.00002001974,0.01084667,0.0002939339,0.00001138122,0.0002444551,0.0003318243,0.0001288627,0.003541551,0.0003959061,0.984148,0.00002914806],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.03394577,0.01407917,0.01258854,0.008273409,0.002700977,0.002246854,0.04213946,0.003766599,0.8802591],"genre_scores_gemma":[0.1499705,0.02400841,0.04187486,0.007302974,0.0007969647,0.0008204973,0.0582674,0.002222323,0.714736],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.3668666,"threshold_uncertainty_score":0.7380544,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03287884410848713,"score_gpt":0.3294791601175436,"score_spread":0.2966003160090565,"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."}}