{"id":"https://openalex.org/W2010653294","doi":"https://doi.org/10.1038/clpt.2011.89","title":"Regulatory Science as a Bridge Between Science and Society","display_name":"Regulatory Science as a Bridge Between Science and Society","publication_year":2011,"publication_date":"2011-06-21","ids":{"openalex":"https://openalex.org/W2010653294","doi":"https://doi.org/10.1038/clpt.2011.89","mag":"2010653294","pmid":"https://pubmed.ncbi.nlm.nih.gov/21691273"},"language":"en","primary_location":{"id":"doi:10.1038/clpt.2011.89","doi":"https://doi.org/10.1038/clpt.2011.89","is_oa":false,"landing_page_url":"https://doi.org/10.1038/clpt.2011.89","pdf_url":null,"source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","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":"Clinical Pharmacology &amp; Therapeutics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.2133/dmpk.25.3","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5043272972","display_name":"Toshiyoshi Tominaga","orcid":"https://orcid.org/0000-0002-5187-4272","observed_orcids":["https://orcid.org/0000-0002-5187-4272"]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":true,"raw_author_name":"T Tominaga","raw_affiliation_strings":["Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. tominagatoshiyoshi@pmda.go.jp","Pharmaceuticals and Medical Devices Agency; Tokyo Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. tominagatoshiyoshi@pmda.go.jp","institution_ids":["https://openalex.org/I91962293"]},{"raw_affiliation_string":"Pharmaceuticals and Medical Devices Agency; Tokyo Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5113882654","display_name":"Yasuko Asahina","orcid":"https://orcid.org/0009-0005-2446-033X","observed_orcids":["https://orcid.org/0009-0005-2446-033X"]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Y Asahina","raw_affiliation_strings":["Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031727238","display_name":"Yoshiaki Uyama","orcid":"https://orcid.org/0000-0002-0430-9887","observed_orcids":["https://orcid.org/0000-0002-0430-9887"]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Y Uyama","raw_affiliation_strings":["Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"last","author":{"id":null,"display_name":"T Kondo","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"T Kondo","raw_affiliation_strings":["Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5043272972"],"corresponding_institution_ids":["https://openalex.org/I91962293"],"apc_list":{"value":4410,"currency":"USD","value_usd":4410},"apc_paid":null,"fwci":2.7253,"has_fulltext":false,"cited_by_count":31,"citation_normalized_percentile":{"value":0.91010064,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":98},"biblio":{"volume":"90","issue":"1","first_page":"29","last_page":"31"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.23019999265670776,"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"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.23019999265670776,"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/T13417","display_name":"Biomedical Ethics and Regulation","score":0.18490000069141388,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.16089999675750732,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"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/regulatory-science","display_name":"regulatory science","score":1.0},{"id":"https://openalex.org/keywords/drug-regulation","display_name":"drug regulation","score":0.8880000114440918},{"id":"https://openalex.org/keywords/rosiglitazone","display_name":"rosiglitazone","score":0.8259999752044678},{"id":"https://openalex.org/keywords/risk-benefit-assessment","display_name":"risk-benefit assessment","score":0.8579999804496765},{"id":"https://openalex.org/keywords/drug-approval-decisions","display_name":"drug approval decisions","score":0.5600000023841858},{"id":"https://openalex.org/keywords/science-society-interface","display_name":"science-society interface","score":0.7089999914169312},{"id":"https://openalex.org/keywords/drug-development","display_name":"drug development","score":0.6940000057220459}],"concepts":[{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.8005064129829407},{"id":"https://openalex.org/C63433958","wikidata":"https://www.wikidata.org/wiki/Q1774688","display_name":"Clinical pharmacology","level":2,"score":0.601242184638977},{"id":"https://openalex.org/C168031717","wikidata":"https://www.wikidata.org/wiki/Q1530280","display_name":"Balance (ability)","level":2,"score":0.5051034092903137},{"id":"https://openalex.org/C100776233","wikidata":"https://www.wikidata.org/wiki/Q2532492","display_name":"Bridge (graph theory)","level":2,"score":0.45607665181159973},{"id":"https://openalex.org/C2780152017","wikidata":"https://www.wikidata.org/wiki/Q424771","display_name":"Rosiglitazone","level":3,"score":0.45301467180252075},{"id":"https://openalex.org/C55587333","wikidata":"https://www.wikidata.org/wiki/Q1133029","display_name":"Engineering ethics","level":1,"score":0.4338074326515198},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.3831063210964203},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.37932878732681274},{"id":"https://openalex.org/C539667460","wikidata":"https://www.wikidata.org/wiki/Q2414942","display_name":"Management science","level":1,"score":0.3763173222541809},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.300143301486969},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.28406059741973877},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.24435245990753174},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.18825390934944153},{"id":"https://openalex.org/C169760540","wikidata":"https://www.wikidata.org/wiki/Q207011","display_name":"Neuroscience","level":1,"score":0.10408604145050049},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.08320391178131104},{"id":"https://openalex.org/C170493617","wikidata":"https://www.wikidata.org/wiki/Q208467","display_name":"Receptor","level":2,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D003627","descriptor_name":"Data Interpretation, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003657","descriptor_name":"Decision Making","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":false},{"descriptor_ui":"D004345","descriptor_name":"Drug Industry","qualifier_ui":"Q000639","qualifier_name":"trends","is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006077","descriptor_name":"Government Agencies","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D010601","descriptor_name":"Pharmacology, Clinical","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"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":"D016208","descriptor_name":"Databases, Factual","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1038/clpt.2011.89","doi":"https://doi.org/10.1038/clpt.2011.89","is_oa":false,"landing_page_url":"https://doi.org/10.1038/clpt.2011.89","pdf_url":null,"source":{"id":"https://openalex.org/S159852663","display_name":"Clinical Pharmacology & Therapeutics","issn_l":"0009-9236","issn":["0009-9236","1085-8733","1532-6535"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","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":"Clinical Pharmacology &amp; Therapeutics","raw_type":"journal-article"},{"id":"pmid:21691273","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/21691273","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":"Clinical pharmacology and therapeutics","raw_type":"Journal Article"},{"id":"pmh:oai:irdb.nii.ac.jp:07563:0007339919","doi":null,"is_oa":true,"landing_page_url":"https://doi.org/10.2133/dmpk.25.3","pdf_url":null,"source":{"id":"https://openalex.org/S7407056385","display_name":"Institutional Repositories DataBase (IRDB)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I184597095","host_organization_name":"National Institute of Informatics","host_organization_lineage":["https://openalex.org/I184597095"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Regulatory science as a bridge between science and society","raw_type":"journal article"}],"best_oa_location":{"id":"pmh:oai:irdb.nii.ac.jp:07563:0007339919","doi":null,"is_oa":true,"landing_page_url":"https://doi.org/10.2133/dmpk.25.3","pdf_url":null,"source":{"id":"https://openalex.org/S7407056385","display_name":"Institutional Repositories DataBase (IRDB)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I184597095","host_organization_name":"National Institute of Informatics","host_organization_lineage":["https://openalex.org/I184597095"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Regulatory science as a bridge between science and society","raw_type":"journal article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.5683000087738037,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":4,"referenced_works":["https://openalex.org/W1975777549","https://openalex.org/W2016681812","https://openalex.org/W2023970099","https://openalex.org/W2987237028"],"related_works":["https://openalex.org/W4243659537","https://openalex.org/W2438660519","https://openalex.org/W2968918021","https://openalex.org/W2332414940","https://openalex.org/W2414232526","https://openalex.org/W2600729965","https://openalex.org/W2166328800","https://openalex.org/W2921553656","https://openalex.org/W2075076514","https://openalex.org/W4300920078"],"abstract_inverted_index":{"Development":[0],"of":[1,11,17,30,50],"innovative":[2],"drugs":[3],"has":[4],"recently":[5],"become":[6],"more":[7],"difficult.":[8],"The":[9],"case":[10],"rosiglitazone":[12],"shows":[13],"the":[14,19,26,44],"extreme":[15],"difficulty":[16],"making":[18],"regulatory":[20,39],"decision":[21],"that":[22,38],"will":[23,55],"best":[24],"balance":[25],"benefits":[27],"and":[28],"risks":[29],"a":[31,35],"drug.":[32],"There":[33],"is":[34,59],"high":[36],"expectation":[37],"science":[40],"(RS)":[41],"can":[42],"improve":[43],"situation.":[45],"However,":[46],"without":[47],"user":[48],"understanding":[49],"its":[51],"basic":[52],"characteristics,":[53],"RS":[54],"not":[56],"deliver":[57],"what":[58],"expected.":[60],"Clinical":[61],"Pharmacology":[62],"&":[63],"Therapeutics":[64],"(2011)":[65],"90":[66],"1,":[67],"29\u201331.":[68],"doi:10.1038/clpt.2011.89":[69]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2024,"cited_by_count":1},{"year":2023,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":2},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":3},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":6},{"year":2013,"cited_by_count":5},{"year":2012,"cited_by_count":4}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2016-06-24T00:00:00"}
