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Volumn 4, Issue 1, 2013, Pages

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

Author keywords

Comparative effectiveness research; Drug information services; Drug interactions; Drug labeling; Linked data; Pharmacokinetics; Regulatory science; Scientific discourse ontologies; Treatment effectiveness; Treatment efficacy

Indexed keywords


EID: 84931093028     PISSN: None     EISSN: 20411480     Source Type: Journal    
DOI: 10.1186/2041-1480-4-5     Document Type: Article
Times cited : (16)

References (50)
  • 1
    • 0036224186 scopus 로고    scopus 로고
    • The product label: how pharmacokinetics and pharmacodynamics reach the prescriber
    • Marroum PJ, Gobburu J: The product label: how pharmacokinetics and pharmacodynamics reach the prescriber. Clin Pharmacokinetics 2002,41(3):161-169. [ http://www.ncbi.nlm.nih.gov/pubmed/11929317 ]. [PMID: 11929317]
    • (2002) Clin Pharmacokinetics , vol.41 , Issue.3 , pp. 161-169
    • Marroum, P.J.1    Gobburu, J.2
  • 3
    • 84861232675 scopus 로고    scopus 로고
    • Last Accessed: 03/23/2012
    • FDA: CFR - Code of Federal Regulations Title 21. 2011. [ http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=201.57 ]. [Last Accessed: 03/23/2012]
    • (2011) CFR - Code of Federal Regulations Title 21
  • 4
    • 84859533106 scopus 로고    scopus 로고
    • Age-related changes in antidepressant pharmacokinetics and potential drug-drug interactions: a comparison of evidence-based literature and package insert information
    • Boyce RD, Handler SM, Karp JF, Hanlon JT: Age-related changes in antidepressant pharmacokinetics and potential drug-drug interactions: a comparison of evidence-based literature and package insert information. Am J Geriatric Pharmacother 2012,10(2):139-150. [PMID: 22285509]
    • (2012) Am J Geriatric Pharmacother , vol.10 , Issue.2 , pp. 139-150
    • Boyce, R.D.1    Handler, S.M.2    Karp, J.F.3    Hanlon, J.T.4
  • 5
    • 20444484157 scopus 로고    scopus 로고
    • Assessment of geriatric information on the drug label for commonly prescribed drugs in older people
    • Steinmetz KL, Coley KC, Pollock BG: Assessment of geriatric information on the drug label for commonly prescribed drugs in older people. J Am Geriatrics Soc 2005,53(5):891-894. [ http://www.ncbi.nlm.nih.gov/pubmed/15877571 ]. [PMID: 15877571]
    • (2005) J Am Geriatrics Soc , vol.53 , Issue.5 , pp. 891-894
    • Steinmetz, K.L.1    Coley, K.C.2    Pollock, B.G.3
  • 6
    • 79952495577 scopus 로고    scopus 로고
    • Evaluation of warfarin drug interaction listings in US product information for warfarin and interacting drugs
    • Hines L, Ceron-Cabrera D, Romero K, Anthony M, Woosley R, Armstrong E, Malone D: Evaluation of warfarin drug interaction listings in US product information for warfarin and interacting drugs. Clin Ther 2011, 33:36-45. [ http://www.ncbi.nlm.nih.gov/pubmed/21397772 ]. [PMID: 21397772]
    • (2011) Clin Ther , vol.33 , pp. 36-45
    • Hines, L.1    Ceron-Cabrera, D.2    Romero, K.3    Anthony, M.4    Woosley, R.5    Armstrong, E.6    Malone, D.7
  • 7
    • 77949265998 scopus 로고    scopus 로고
    • Beyond genes, proteins, and abstracts: Identifying scientific claims from full-text biomedical articles
    • Blake C: Beyond genes, proteins, and abstracts: Identifying scientific claims from full-text biomedical articles. J Biomed Informatics 2010,43(2):173-189.
    • (2010) J Biomed Informatics , vol.43 , Issue.2 , pp. 173-189
    • Blake, C.1
  • 11
    • 45449096083 scopus 로고    scopus 로고
    • KonneX-SALT: first steps towards a semantic claim federation infrastructure
    • Edited by: Bechhofer S, Hauswirth M, Hoffmann J, Koubarakis M. Berlin /Heidelberg: Springer
    • Groza T, Handschuh S, Möller K, Decker S: KonneX-SALT: first steps towards a semantic claim federation infrastructure. In The Semantic Web: Research and Applications, Volume 5021 of Lecture Notes in Computer Science. Edited by: Bechhofer S, Hauswirth M, Hoffmann J, Koubarakis M. Berlin /Heidelberg: Springer; 2008:80-94. [ http://dx.doi.org/10.1007/978-3-540-68234-9_9 ]
    • (2008) The Semantic Web: Research and Applications, Volume 5021 of Lecture Notes in Computer Science , pp. 80-94
    • Groza, T.1    Handschuh, S.2    Möller, K.3    Decker, S.4
  • 13
    • 85046448768 scopus 로고    scopus 로고
    • Linked Data: evolving the web into a global data space
    • Heath T, Bizer C: Linked Data: evolving the web into a global data space. Synth Lectures on the Semantic Web: Theory and Technol 2011, 1:1-136. [ http://www.morganclaypool.com/doi/abs/10.2200/S00334ED1V01Y201102WBE001 ]
    • (2011) Synth Lectures on the Semantic Web: Theory and Technol , vol.1 , pp. 1-136
    • Heath, T.1    Bizer, C.2
  • 14
    • 84867776378 scopus 로고    scopus 로고
    • Inhibitory metabolic drug interactions with newer psychotropic drugs: inclusion in package inserts and influences of concurrence in drug interaction screening software
    • Boyce RD, Collins C, Clayton M, Kloke J, Horn JR: Inhibitory metabolic drug interactions with newer psychotropic drugs: inclusion in package inserts and influences of concurrence in drug interaction screening software. Ann Pharmacotherapy 2012,46(10):1287-98. [ http://www.theannals.com/content/early/2012/10/02/aph.1R150 ]
    • (2012) Ann Pharmacotherapy , vol.46 , Issue.10 , pp. 1287-1298
    • Boyce, R.D.1    Collins, C.2    Clayton, M.3    Kloke, J.4    Horn, J.R.5
  • 18
    • 72849125569 scopus 로고    scopus 로고
    • Comparison of critical drug-drug interaction listings: the Department of Veterans Affairs medical system and standard reference compendia
    • Olvey E, Clauschee S, Malone D: Comparison of critical drug-drug interaction listings: the Department of Veterans Affairs medical system and standard reference compendia. Clin Pharmacol Ther 2010, 87:48-51. [ http://www.ncbi.nlm.nih.gov/pubmed/19890252 ]. [PMID: 19890252]
    • (2010) Clin Pharmacol Ther , vol.87 , pp. 48-51
    • Olvey, E.1    Clauschee, S.2    Malone, D.3
  • 19
    • 70350571681 scopus 로고    scopus 로고
    • Computing with evidence Part II: An evidential approach to predicting metabolic drug-drug interactions
    • Boyce R, Collins C, Horn J, Kalet I: Computing with evidence Part II: An evidential approach to predicting metabolic drug-drug interactions. J Biomed Informatics 2009,42(6):990-1003. [ http://www.ncbi.nlm.nih.gov/pubmed/19539050 ]. [PMID: 19539050]
    • (2009) J Biomed Informatics , vol.42 , Issue.6 , pp. 990-1003
    • Boyce, R.1    Collins, C.2    Horn, J.3    Kalet, I.4
  • 20
    • 84859229402 scopus 로고    scopus 로고
    • Automatic recognition of conceptualisation zones in scientific articles and two life science applications
    • Liakata M, Saha S, Dobnik S, Batchelor C, D RS: Automatic recognition of conceptualisation zones in scientific articles and two life science applications. Bioinformatics 2012,28(7):991-1000.
    • (2012) Bioinformatics , vol.28 , Issue.7 , pp. 991-1000
    • Liakata, M.1    Saha, S.2    Dobnik, S.3    Batchelor, C.4
  • 21
    • 0017360990 scopus 로고
    • PMID: 843571
    • Landis JR, Koch GG, The measurement of observer agreement for categorical data: Biometrics. 1977, 33:159-174. [ http://www.ncbi.nlm.nih.gov/pubmed/843571 ]. [PMID: 843571]
    • (1977) Biometrics , vol.33 , pp. 159-174
    • Landis, J.R.1    Koch, G.G.2
  • 22
    • 0034936466 scopus 로고    scopus 로고
    • Escitalopram (S-citalopram) and its metabolites in vitro: cytochromes mediating biotransformation, inhibitory effects, and comparison to R-citalopram
    • von Moltke L, Greenblatt D, Giancarlo G, Granda B, Harmatz J, Shader R: Escitalopram (S-citalopram) and its metabolites in vitro: cytochromes mediating biotransformation, inhibitory effects, and comparison to R-citalopram. Drug Metabol Dispos: Biol Fate Chem 2001,29(8):1102-1109. [ http://www.ncbi.nlm.nih.gov/pubmed/11454728 ]. [PMID: 11454728]
    • (2001) Drug Metabol Dispos: Biol Fate Chem , vol.29 , Issue.8 , pp. 1102-1109
    • von Moltke, L.1    Greenblatt, D.2    Giancarlo, G.3    Granda, B.4    Harmatz, J.5    Shader, R.6
  • 23
    • 84949868243 scopus 로고    scopus 로고
    • Lexapro (escitalopram) tablets/oral solution
    • Forest Pharmaceuticals: Lexapro (escitalopram) tablets/oral solution. FDA-Approved Drug Product Labeling 2009.
    • (2009) FDA-Approved Drug Product Labeling
  • 24
    • 84865415281 scopus 로고    scopus 로고
    • FDA Guideline: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling
    • Rockville, MD: Food and Drug Administration
    • FDA: FDA Guideline: Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling. Rockville, MD: Food and Drug Administration; 2006. [ http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072101.pdf ]. [Last Accessed: 03/31/2010]
    • (2006)
  • 25
    • 84949868244 scopus 로고    scopus 로고
    • RIFADIN (rifampin) capsule, RIFADIN IV (rifampin) injection, powder, lyophilized, for solution
    • Sanofi-Aventis: RIFADIN (rifampin) capsule, RIFADIN IV (rifampin) injection, powder, lyophilized, for solution. FDA-Approved Drug Product Labeling 2010.
    • (2010) FDA-Approved Drug Product Labeling
  • 26
    • 79957642848 scopus 로고    scopus 로고
    • Critical issues associated with drug-drug interactions: Highlights of a multistakeholder conference
    • Hines LE, Murphy JE, Grizzle AJ, Malone DC: Critical issues associated with drug-drug interactions: Highlights of a multistakeholder conference. Am J Health-Syst Pharmacy 2011,68(10):941-946. [ http://www.ajhp.org/content/68/10/941.short ]
    • (2011) Am J Health-Syst Pharmacy , vol.68 , Issue.10 , pp. 941-946
    • Hines, L.E.1    Murphy, J.E.2    Grizzle, A.J.3    Malone, D.C.4
  • 27
    • 70350571792 scopus 로고    scopus 로고
    • Computing with evidence Part I: A drug-mechanism evidence taxonomy oriented toward confidence assignment
    • Boyce R, Collins C, Horn J, Kalet I: Computing with evidence Part I: A drug-mechanism evidence taxonomy oriented toward confidence assignment. J Biomed Inform 2009,42(6):979-989.
    • (2009) J Biomed Inform , vol.42 , Issue.6 , pp. 979-989
    • Boyce, R.1    Collins, C.2    Horn, J.3    Kalet, I.4
  • 29
    • 84855594900 scopus 로고    scopus 로고
    • Advancing Regulatory Science at FDA
    • Rockville, MD: Food and Drug Administration
    • FDA: Advancing Regulatory Science at FDA. Rockville, MD: Food and Drug Administration; 2011. [ http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/RegulatoryScience/UCM268225.pdf ]. [Last Accessed: 10/31/2012]
    • (2011)
  • 30
    • 84949868245 scopus 로고    scopus 로고
    • DATSCAN (ioflupane i-123 and iodine) injection, solution
    • Medi-Physics Inc: DATSCAN (ioflupane i-123 and iodine) injection, solution. FDA-approved drug product labeling 2011.
    • (2011) FDA-approved drug product labeling
  • 31
    • 17244380380 scopus 로고    scopus 로고
    • A survey of current work in biomedical text a survey of current work in biomedical text mining
    • Cohen AM, Hersh W: A survey of current work in biomedical text a survey of current work in biomedical text mining. Briefings in Bioinf 2005, 6:57-71.
    • (2005) Briefings in Bioinf , vol.6 , pp. 57-71
    • Cohen, A.M.1    Hersh, W.2
  • 32
    • 77953917404 scopus 로고    scopus 로고
    • S P: Event extraction for systems biology by text mining the literature
    • Ananiadou S, Tsujii J, S P: Event extraction for systems biology by text mining the literature. Trends Biotechnol 2010,28(7):381-390.
    • (2010) Trends Biotechnol , vol.28 , Issue.7 , pp. 381-390
    • Ananiadou, S.1    Tsujii, J.2
  • 33
    • 79957577277 scopus 로고    scopus 로고
    • A quantitative analysis of adverse events and "overwarning" in drug labeling
    • Duke JFJ: A quantitative analysis of adverse events and "overwarning" in drug labeling. Arch Internal Med 2011,171(10):941-954. [ http://dx.doi.org/10.1001/archinternmed.2011.182 ]
    • (2011) Arch Internal Med , vol.171 , Issue.10 , pp. 941-954
    • Duke, J.F.J.1
  • 34
    • 76149120425 scopus 로고    scopus 로고
    • A side effect resource to capture phenotypic effects of drugs
    • Kuhn M, Campillos M, Letunic I, Jensen LJ, Bork P: A side effect resource to capture phenotypic effects of drugs. Mol Syst Biol 2010, 6:343. [PMID: 20087340]
    • (2010) Mol Syst Biol , vol.6 , pp. 343
    • Kuhn, M.1    Campillos, M.2    Letunic, I.3    Jensen, L.J.4    Bork, P.5
  • 35
    • 85119344799 scopus 로고    scopus 로고
    • Using natural language processing to extract drug-drug interaction information from package inserts
    • Montréal, Canada: Association for Computational Linguistics
    • Boyce R, Gardner G, Harkema H: Using natural language processing to extract drug-drug interaction information from package inserts. In BioNLP: Proceedings of the 2012 Workshop on Biomedical Natural Language Processing. Montréal, Canada: Association for Computational Linguistics; 2012:206-213. [ http://www.aclweb.org/anthology/W12-2426 ]
    • (2012) BioNLP: Proceedings of the 2012 Workshop on Biomedical Natural Language Processing , pp. 206-213
    • Boyce, R.1    Gardner, G.2    Harkema, H.3
  • 36
    • 82355160710 scopus 로고    scopus 로고
    • Network-based analysis and characterization of adverse drugâAŞdrug interactions
    • Takarabe M, Shigemizu D, Kotera M, Goto S, Kanehisa M: Network-based analysis and characterization of adverse drugâAŞdrug interactions. J Chem Inf Model 2011,51(11):2977-2985. [ http://dx.doi.org/10.1021/ci200367w ]
    • (2011) J Chem Inf Model , vol.51 , Issue.11 , pp. 2977-2985
    • Takarabe, M.1    Shigemizu, D.2    Kotera, M.3    Goto, S.4    Kanehisa, M.5
  • 37
    • 84858282652 scopus 로고    scopus 로고
    • Summary of Product Characteristics content extraction for a safe drugs usage
    • Rubrichi S, Quaglini S: Summary of Product Characteristics content extraction for a safe drugs usage. J Biomed Informatics 2012,45(2):231-239. [ http://www.ncbi.nlm.nih.gov/pubmed/22094356 ]. [PMID: 22094356]
    • (2012) J Biomed Informatics , vol.45 , Issue.2 , pp. 231-239
    • Rubrichi, S.1    Quaglini, S.2
  • 41
    • 78149308924 scopus 로고    scopus 로고
    • Using text to build semantic networks for pharmacogenomics
    • Coulet A, Shah NH, Garten Y, Musen M, Altman RB: Using text to build semantic networks for pharmacogenomics. J Biomed Informatics 2010,43(6):1009-1019. [PMID: 20723615]
    • (2010) J Biomed Informatics , vol.43 , Issue.6 , pp. 1009-1019
    • Coulet, A.1    Shah, N.H.2    Garten, Y.3    Musen, M.4    Altman, R.B.5
  • 42
    • 84858300305 scopus 로고    scopus 로고
    • Discovery and explanation of drug-drug interactions via text mining
    • Pac Symp Biocomputing
    • Percha B, Garten Y, Altman RB: Discovery and explanation of drug-drug interactions via text mining. Pac Symp Biocomputing. Pac Symp Biocomputing 2012, 410-421. [ http://view.ncbi.nlm.nih.gov/pubmed/22174296 ]
    • (2012) Pac Symp Biocomputing , pp. 410-421
    • Percha, B.1    Garten, Y.2    Altman, R.B.3
  • 44
    • 77956517407 scopus 로고    scopus 로고
    • Discovering drug-drug interactions: a text-mining and reasoning approach based on properties of drug metabolism
    • Tari L, Anwar S, Liang S, Cai J, Baral C: Discovering drug-drug interactions: a text-mining and reasoning approach based on properties of drug metabolism. Bioinformatics (Oxford, England) 2010,26(18):i547-553. [PMID: 20823320]
    • (2010) Bioinformatics (Oxford, England) , vol.26 , Issue.18 , pp. i547-553
    • Tari, L.1    Anwar, S.2    Liang, S.3    Cai, J.4    Baral, C.5
  • 45
    • 84949868247 scopus 로고    scopus 로고
    • Providing Regulatory Submissions in Electronic Format - Content of Labeling
    • Rockville, MD 2005. Food and Drug Administration, Rockville, MD
    • FDA: Providing Regulatory Submissions in Electronic Format - Content of Labeling. Guidance for Industry UCM072331, Food and Drug Administration, Rockville, MD 2005. [ http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072331.pdf ] Guidance for Industry UCM072331, Food and Drug Administration, Rockville, MD 2005.
    • (2005) Guidance for Industry UCM072331, Food and Drug Administration
  • 47
    • 84892932570 scopus 로고    scopus 로고
    • National Library of Medicine: DailyMed. 2012. [ http://dailymed.nlm.nih.gov/dailymed/about.cfm ]
    • (2012) DailyMed
  • 48
    • 84871346159 scopus 로고    scopus 로고
    • The D2RQ platform - accessing relational databases as virtual RDF graphs
    • Cyganiak R: The D2RQ platform - accessing relational databases as virtual RDF graphs. 2012. [ http://d2rq.org/ ].
    • (2012)
    • Cyganiak, R.1
  • 49
    • 84949868248 scopus 로고    scopus 로고
    • Geriatric Dosage Handbook 2012: Including Clinical Recommendations and Monitoring Guidelines
    • Semla TP, Beizer JL, Higbee MD (Eds): Geriatric Dosage Handbook 2012: Including Clinical Recommendations and Monitoring Guidelines. Lexi Comp. 2011.
    • (2011) Lexi Comp
    • Semla, T.P.1    Beizer, J.L.2    Higbee, M.D.3


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