{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T18:00:53Z","timestamp":1792173653719,"version":"4.4.0"},"reference-count":18,"publisher":"Wiley","issue":"16","license":[{"start":{"date-parts":[[2008,3,14]],"date-time":"2008-03-14T00:00:00Z","timestamp":1205452800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2008,7,20]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Interaction between drug substances may yield excessive risk of adverse drug reactions (ADRs) when two drugs are taken in combination. Collections of individual case safety reports (ICSRs) related to suspected ADR incidents in clinical practice have proven to be very useful in post\u2010marketing surveillance for pairwise drug\u2013ADR associations, but have yet to reach their full potential for drug\u2013drug interaction surveillance. In this paper, we implement and evaluate a shrinkage observed\u2010to\u2010expected ratio for exploratory analysis of suspected drug\u2013drug interaction in ICSR data, based on comparison with an additive risk model. We argue that the limited success of previously proposed methods for drug\u2013drug interaction detection based on ICSR data may be due to an underlying assumption that the absence of interaction is equivalent to having multiplicative risk factors. We provide empirical examples of established drug\u2013drug interaction highlighted with our proposed approach that go undetected with logistic regression. A database wide screen for suspected drug\u2013drug interaction in the entire WHO database is carried out to demonstrate the feasibility of the proposed approach. As always in the analysis of ICSRs, the clinical validity of hypotheses raised with the proposed method must be further reviewed and evaluated by subject matter experts. Copyright \u00a9 2008 John Wiley &amp; Sons, Ltd.<\/jats:p>","DOI":"10.1002\/sim.3247","type":"journal-article","created":{"date-parts":[[2008,3,14]],"date-time":"2008-03-14T12:47:45Z","timestamp":1205498865000},"page":"3057-3070","source":"Crossref","is-referenced-by-count":184,"title":["A statistical methodology for drug\u2013drug interaction surveillance"],"prefix":"10.1002","volume":"27","author":[{"given":"G. Niklas","family":"Nor\u00e9n","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolf","family":"Sundberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Bate","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I. Ralph","family":"Edwards","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2008,3,14]]},"reference":[{"key":"e_1_2_1_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.1988.tb03357.x"},{"key":"e_1_2_1_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/0140-6736(90)91669-2"},{"key":"e_1_2_1_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10618-006-0052-8"},{"key":"e_1_2_1_5_2","first-page":"591","volume-title":"Stephens' Detection of New Adverse Drug Reactions","author":"Stephens MDB","year":"2004"},{"key":"e_1_2_1_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050466"},{"key":"e_1_2_1_7_2","first-page":"888","volume-title":"Davies's Textbook of Adverse Drug Reactions","author":"Pirmohamed M","year":"1998"},{"key":"e_1_2_1_8_2","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.aje.a113015"},{"key":"e_1_2_1_9_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2125.1999.00957.x"},{"key":"e_1_2_1_10_2","doi-asserted-by":"publisher","DOI":"10.1007\/s002280000215"},{"key":"e_1_2_1_11_2","doi-asserted-by":"crossref","unstructured":"DuMouchelW PregibonD.Empirical Bayes screening for multi\u2010item associations. Proceedings of the Seventh ACM SIGKDD International Conference on Knowledge Discovery and Data Mining San Francisco California 2001;67\u201376.","DOI":"10.1145\/502512.502526"},{"key":"e_1_2_1_12_2","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2473"},{"key":"e_1_2_1_13_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.885"},{"issue":"1","key":"e_1_2_1_14_2","first-page":"S247","article-title":"Using disproportional analysis as a tool to explore severe drug\u2013drug interactions in AERS database","volume":"13","author":"Yang X","year":"2004","journal-title":"Pharmacoepidemiology and Drug Safety"},{"key":"e_1_2_1_15_2","doi-asserted-by":"publisher","DOI":"10.1097\/00004583-200108000-00003"},{"key":"e_1_2_1_16_2","doi-asserted-by":"publisher","DOI":"10.1093\/aje\/kwg113"},{"key":"e_1_2_1_17_2","first-page":"301","volume-title":"Stephens' Detection of New Adverse Drug Reactions","author":"Evans SJW","year":"2004"},{"key":"e_1_2_1_18_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.894"},{"issue":"1","key":"e_1_2_1_19_2","first-page":"106","article-title":"Linking spontaneous reports with pharmacogenetics","volume":"97","author":"Strandell J","year":"2005","journal-title":"Basic and Clinical Pharmacology and Toxicology"}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fsim.3247","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.3247","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,14]],"date-time":"2023-11-14T19:30:57Z","timestamp":1699990257000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.3247"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2008,3,14]]},"references-count":18,"journal-issue":{"issue":"16","published-print":{"date-parts":[[2008,7,20]]}},"alternative-id":["10.1002\/sim.3247"],"URL":"https:\/\/doi.org\/10.1002\/sim.3247","archive":["Portico"],"relation":{},"ISSN":["0277-6715","1097-0258"],"issn-type":[{"value":"0277-6715","type":"print"},{"value":"1097-0258","type":"electronic"}],"subject":[],"published":{"date-parts":[[2008,3,14]]}}}