{"id":"https://openalex.org/W1546879740","doi":"https://doi.org/10.1002/sim.6510","title":"Signal detection in FDA AERS database using Dirichlet process","display_name":"Signal detection in FDA AERS database using Dirichlet process","publication_year":2015,"publication_date":"2015-04-29","ids":{"openalex":"https://openalex.org/W1546879740","doi":"https://doi.org/10.1002/sim.6510","mag":"1546879740","pmid":"https://pubmed.ncbi.nlm.nih.gov/25924820"},"language":"en","primary_location":{"id":"doi:10.1002/sim.6510","doi":"https://doi.org/10.1002/sim.6510","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.6510","pdf_url":null,"source":{"id":"https://openalex.org/S55189604","display_name":"Statistics in Medicine","issn_l":"0277-6715","issn":["0277-6715","1097-0258"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Statistics in Medicine","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":null,"display_name":"Na Hu","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I76835614","display_name":"University of Missouri","ror":"https://ror.org/02ymw8z06","country_code":"US","type":"education","lineage":["https://openalex.org/I76835614"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Na Hu","raw_affiliation_strings":["Department of Statistics, University of Missouri, MO 65201, Columbia, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Statistics, University of Missouri, MO 65201, Columbia, U.S.A","institution_ids":["https://openalex.org/I76835614"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5101995001","display_name":"Lan Huang","orcid":"https://orcid.org/0000-0003-2290-7466","observed_orcids":["https://orcid.org/0000-0003-2290-7466"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Lan Huang","raw_affiliation_strings":["Office of Biostatistics, CDER, FDA, Silver Spring, 20993, MD, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Biostatistics, CDER, FDA, Silver Spring, 20993, MD, U.S.A","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5050221788","display_name":"Ram C. Tiwari","orcid":"https://orcid.org/0000-0002-6604-5733","observed_orcids":["https://orcid.org/0000-0002-6604-5733"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Ram C. Tiwari","raw_affiliation_strings":["Office of Biostatistics, CDER, FDA, Silver Spring, 20993, MD, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Biostatistics, CDER, FDA, Silver Spring, 20993, MD, U.S.A","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5101995001"],"corresponding_institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"],"apc_list":{"value":5450,"currency":"USD","value_usd":5450},"apc_paid":null,"fwci":1.058,"has_fulltext":false,"cited_by_count":20,"citation_normalized_percentile":{"value":0.75460476,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":97},"biblio":{"volume":"34","issue":"19","first_page":"2725","last_page":"2742"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9940999746322632,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9940999746322632,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.0024999999441206455,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11819","display_name":"Data-Driven Disease Surveillance","score":0.0007999999797903001,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/drug-safety-signal-detection","display_name":"drug safety signal detection","score":0.7820000052452087},{"id":"https://openalex.org/keywords/adverse-event-reporting","display_name":"adverse event reporting","score":0.6690000295639038},{"id":"https://openalex.org/keywords/fda-adverse-event-reporting-system","display_name":"FDA Adverse Event Reporting System","score":0.8679999709129333},{"id":"https://openalex.org/keywords/poisson-dirichlet-process","display_name":"Poisson-Dirichlet process","score":0.9869999885559082},{"id":"https://openalex.org/keywords/nonparametric-priors","display_name":"nonparametric priors","score":0.9210000038146973},{"id":"https://openalex.org/keywords/reporting-rates","display_name":"reporting rates","score":0.6370000243186951},{"id":"https://openalex.org/keywords/hierarchical-models","display_name":"hierarchical models","score":0.5529999732971191},{"id":"https://openalex.org/keywords/zero-counts","display_name":"zero counts","score":0.5649999976158142},{"id":"https://openalex.org/keywords/statins","display_name":"statins","score":0.7400000095367432},{"id":"https://openalex.org/keywords/bayesian-model-selection","display_name":"Bayesian model selection","score":0.7919999957084656},{"id":"https://openalex.org/keywords/false-discovery-rate","display_name":"false discovery rate","score":0.7730000019073486}],"concepts":[{"id":"https://openalex.org/C162376815","wikidata":"https://www.wikidata.org/wiki/Q2158281","display_name":"Frequentist inference","level":4,"score":0.7061520218849182},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.6515830755233765},{"id":"https://openalex.org/C2781280628","wikidata":"https://www.wikidata.org/wiki/Q5280766","display_name":"Dirichlet process","level":3,"score":0.6291007995605469},{"id":"https://openalex.org/C107673813","wikidata":"https://www.wikidata.org/wiki/Q812534","display_name":"Bayesian probability","level":2,"score":0.5536540150642395},{"id":"https://openalex.org/C102366305","wikidata":"https://www.wikidata.org/wiki/Q1097688","display_name":"Nonparametric statistics","level":2,"score":0.5220327377319336},{"id":"https://openalex.org/C100906024","wikidata":"https://www.wikidata.org/wiki/Q205692","display_name":"Poisson distribution","level":2,"score":0.5050199627876282},{"id":"https://openalex.org/C124101348","wikidata":"https://www.wikidata.org/wiki/Q172491","display_name":"Data mining","level":1,"score":0.46790844202041626},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.4503744840621948},{"id":"https://openalex.org/C169214877","wikidata":"https://www.wikidata.org/wiki/Q981016","display_name":"Dirichlet distribution","level":3,"score":0.43745172023773193},{"id":"https://openalex.org/C160234255","wikidata":"https://www.wikidata.org/wiki/Q812535","display_name":"Bayesian inference","level":3,"score":0.351225882768631},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.25906306505203247},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.21696707606315613},{"id":"https://openalex.org/C134306372","wikidata":"https://www.wikidata.org/wiki/Q7754","display_name":"Mathematical analysis","level":1,"score":0.0},{"id":"https://openalex.org/C182310444","wikidata":"https://www.wikidata.org/wiki/Q1332643","display_name":"Boundary value problem","level":2,"score":0.0}],"mesh":[{"descriptor_ui":"D001499","descriptor_name":"Bayes Theorem","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003198","descriptor_name":"Computer Simulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016012","descriptor_name":"Poisson Distribution","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016013","descriptor_name":"Likelihood Functions","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016017","descriptor_name":"Odds Ratio","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016208","descriptor_name":"Databases, Factual","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016907","descriptor_name":"Adverse Drug Reaction Reporting Systems","qualifier_ui":"Q000458","qualifier_name":"organization & administration","is_major_topic":false},{"descriptor_ui":"D016907","descriptor_name":"Adverse Drug Reaction Reporting Systems","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":true},{"descriptor_ui":"D018709","descriptor_name":"Statistics, Nonparametric","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D057225","descriptor_name":"Data Mining","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D057225","descriptor_name":"Data Mining","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1002/sim.6510","doi":"https://doi.org/10.1002/sim.6510","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.6510","pdf_url":null,"source":{"id":"https://openalex.org/S55189604","display_name":"Statistics in Medicine","issn_l":"0277-6715","issn":["0277-6715","1097-0258"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Statistics in Medicine","raw_type":"journal-article"},{"id":"pmid:25924820","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/25924820","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Statistics in medicine","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.504800021648407,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[{"score":0.7099999785423279,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":35,"referenced_works":["https://openalex.org/W64093801","https://openalex.org/W1542127376","https://openalex.org/W1582019318","https://openalex.org/W1963703587","https://openalex.org/W1967396577","https://openalex.org/W1967555951","https://openalex.org/W1984733681","https://openalex.org/W1988100739","https://openalex.org/W1988355715","https://openalex.org/W1989756416","https://openalex.org/W2015487160","https://openalex.org/W2024211352","https://openalex.org/W2024315245","https://openalex.org/W2027158091","https://openalex.org/W2035283683","https://openalex.org/W2039594635","https://openalex.org/W2057765075","https://openalex.org/W2064716383","https://openalex.org/W2069429561","https://openalex.org/W2072169887","https://openalex.org/W2079244816","https://openalex.org/W2083991698","https://openalex.org/W2089484716","https://openalex.org/W2098730643","https://openalex.org/W2099421969","https://openalex.org/W2118183380","https://openalex.org/W2126832117","https://openalex.org/W2133862683","https://openalex.org/W2151967501","https://openalex.org/W2158299492","https://openalex.org/W2158799342","https://openalex.org/W4238294947","https://openalex.org/W4250143236","https://openalex.org/W4254930281","https://openalex.org/W4310632455"],"related_works":["https://openalex.org/W4415330014","https://openalex.org/W3161831526","https://openalex.org/W2158799342","https://openalex.org/W3047562657","https://openalex.org/W1989756416","https://openalex.org/W2121993659","https://openalex.org/W2070255966","https://openalex.org/W2035283683","https://openalex.org/W4206676870","https://openalex.org/W3085679374"],"abstract_inverted_index":{"In":[0],"the":[1,29,47,52,62,77,99,104,117,125,129,133,141,176,199],"recent":[2],"two":[3],"decades,":[4],"data":[5],"mining":[6],"methods":[7,26],"for":[8,14,33,69,98,196],"signal":[9,70],"detection":[10,71],"have":[11],"been":[12],"developed":[13],"drug":[15],"safety":[16,21],"surveillance,":[17],"using":[18,90,155,198],"large":[19,73,185],"post-market":[20],"data.":[22,202],"Several":[23],"of":[24,31,51,89,128,140,187],"these":[25],"assume":[27],"that":[28],"number":[30],"reports":[32],"each":[34],"drug-adverse":[35,53],"event":[36,54],"combination":[37],"is":[38,67,103,119,144],"a":[39,57,91,95,113,156,184],"Poisson":[40],"random":[41],"variable":[42],"with":[43,106,146],"mean":[44],"proportional":[45],"to":[46,182,192],"unknown":[48],"reporting":[49,100],"rate":[50],"pair.":[55],"Here,":[56],"Bayesian":[58,108,111,157],"method":[59],"based":[60],"on":[61],"Poisson-Dirichlet":[63],"process":[64],"(DP)":[65],"model":[66,143,158,178],"proposed":[68,177],"from":[72],"databases,":[74],"such":[75,164],"as":[76,94,102,165],"Food":[78],"and":[79,124,160,172,179],"Drug":[80],"Administration's":[81],"Adverse":[82],"Event":[83],"Reporting":[84],"System":[85],"(AERS)":[86],"database.":[87],"Instead":[88],"parametric":[92],"distribution":[93,127],"common":[96],"prior":[97],"rates,":[101],"case":[105],"existing":[107],"or":[109],"empirical":[110],"methods,":[112],"nonparametric":[114],"prior,":[115],"namely,":[116],"DP,":[118,130],"used.":[120],"The":[121,138],"precision":[122],"parameter":[123],"baseline":[126],"which":[131],"characterize":[132],"process,":[134],"are":[135,190],"modeled":[136],"hierarchically.":[137],"performance":[139,162],"Poisson-DP":[142],"compared":[145],"some":[147],"other":[148],"models,":[149],"through":[150],"an":[151],"intensive":[152],"simulation":[153],"study":[154],"selection":[159],"frequentist":[161],"characteristics":[163],"type-I":[166],"error,":[167],"false":[168],"discovery":[169],"rate,":[170],"sensitivity,":[171],"power.":[173],"For":[174],"illustration,":[175],"its":[180],"extension":[181],"address":[183],"amount":[186],"zero":[188],"counts":[189],"used":[191],"analyze":[193],"statin":[194],"drugs":[195],"signals":[197],"2006-2011":[200],"AERS":[201]},"counts_by_year":[{"year":2026,"cited_by_count":2},{"year":2025,"cited_by_count":2},{"year":2024,"cited_by_count":1},{"year":2023,"cited_by_count":4},{"year":2022,"cited_by_count":1},{"year":2020,"cited_by_count":4},{"year":2019,"cited_by_count":2},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":2},{"year":2016,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}