{"id":"W3163866919","doi":"10.1007/s40264-021-01078-8","title":"Enhancing Pharmacovigilance from the US Experience: Current Practices and Future Opportunities","year":2021,"lang":"en","type":"review","venue":"Drug Safety","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":16,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"Health Canada","keywords":"Pharmacovigilance; Medicine; Excellence; Best practice; Presentation (obstetrics); Knowledge management; Engineering ethics; Pharmacology; Engineering; Management; Adverse effect; Computer science","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"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":[0.004790541,0.00105443,0.001861828,0.00258889,0.000280347,0.002462193,0.001528709,0.00286403,0.003659186],"category_scores_gemma":[0.005880277,0.0002801348,0.0009651502,0.002922735,0.0008606641,0.002539086,0.001251541,0.003228396,0.00107772],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001431596,"about_ca_system_score_gemma":0.003799598,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002263219,"about_ca_topic_score_gemma":0.004693063,"domain_scores_codex":[0.9990211,0.0002862473,0.0001391306,0.000130886,0.0003482602,0.00007446777],"domain_scores_gemma":[0.9944118,0.003569806,0.0006416955,0.00008117172,0.001026437,0.0002691236],"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":[0.00006562907,0.00005630747,0.0001994239,0.01508526,0.0001401731,0.00007613541,0.00005287882,0.0002046147,0.0002893016,0.002852263,0.0191902,0.9617878],"study_design_scores_gemma":[0.00008907156,0.0001858728,0.001634757,0.03098877,0.0005877277,0.0009623393,0.000162274,0.0002449876,0.000404382,0.004849221,0.9598456,0.00004501305],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.00005126382,0.9982938,0.0001326802,0.001007571,0.0001514254,0.000003468546,0.00001065222,0.000006732948,0.0003424496],"genre_scores_gemma":[0.0005718123,0.9979596,0.0003414403,0.0007101328,0.0002361894,0.00000550664,0.00001891,0.000001843171,0.0001545338],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.004790541,"threshold_uncertainty_score":0.02533513,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.119996193234862,"score_gpt":0.4177286110289148,"score_spread":0.2977324177940528,"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."}}