{"id":"https://openalex.org/W1990411699","doi":"https://doi.org/10.2165/00019053-200119020-00005","title":"Health-Related Quality of Life (HR-QOL) and Regulatory Issues","display_name":"Health-Related Quality of Life (HR-QOL) and Regulatory Issues","publication_year":2001,"publication_date":"2001-01-01","ids":{"openalex":"https://openalex.org/W1990411699","doi":"https://doi.org/10.2165/00019053-200119020-00005","mag":"1990411699","pmid":"https://pubmed.ncbi.nlm.nih.gov/11284382"},"language":"en","primary_location":{"id":"doi:10.2165/00019053-200119020-00005","doi":"https://doi.org/10.2165/00019053-200119020-00005","is_oa":false,"landing_page_url":"https://doi.org/10.2165/00019053-200119020-00005","pdf_url":null,"source":{"id":"https://openalex.org/S43019230","display_name":"PharmacoEconomics","issn_l":"1170-7690","issn":["1170-7690","1179-2027"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-c","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PharmacoEconomics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"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":"https://openalex.org/A5052679679","display_name":"Giovanni Apolone","orcid":"https://orcid.org/0000-0001-5179-104X","observed_orcids":["https://orcid.org/0000-0001-5179-104X"]},"institutions":[{"id":"https://openalex.org/I19630809","display_name":"Mario Negri Institute for Pharmacological Research","ror":"https://ror.org/05aspc753","country_code":"IT","type":"nonprofit","lineage":["https://openalex.org/I19630809","https://openalex.org/I4210110338","https://openalex.org/I4210153126"]}],"countries":["IT"],"is_corresponding":true,"raw_author_name":"Giovanni Apolone","raw_affiliation_strings":["Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy. Apolone@marionegri.it","Istituto di Ricerche Farmacologiche \u2018Mario Negri\u2019, Milano, (Italy)"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy. Apolone@marionegri.it","institution_ids":["https://openalex.org/I19630809"]},{"raw_affiliation_string":"Istituto di Ricerche Farmacologiche \u2018Mario Negri\u2019, Milano, (Italy)","institution_ids":["https://openalex.org/I19630809"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5112160297","display_name":"Gianfranco De Carli","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210128413","display_name":"GlaxoSmithKline (Italy)","ror":"https://ror.org/03fe56089","country_code":"IT","type":"company","lineage":["https://openalex.org/I188950975","https://openalex.org/I4210128413"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Gianfranco De Carli","raw_affiliation_strings":["GlaxoWellcome Italia, Verona, Italy"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"GlaxoWellcome Italia, Verona, Italy","institution_ids":["https://openalex.org/I4210128413"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109124031","display_name":"Massimo Brunetti","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I19630809","display_name":"Mario Negri Institute for Pharmacological Research","ror":"https://ror.org/05aspc753","country_code":"IT","type":"nonprofit","lineage":["https://openalex.org/I19630809","https://openalex.org/I4210110338","https://openalex.org/I4210153126"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Massimo Brunetti","raw_affiliation_strings":["Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157, Milano, Italy","Istituto di Ricerche Farmacologiche \u2018Mario Negri\u2019, Milano, (Italy)"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157, Milano, Italy","institution_ids":["https://openalex.org/I19630809"]},{"raw_affiliation_string":"Istituto di Ricerche Farmacologiche \u2018Mario Negri\u2019, Milano, (Italy)","institution_ids":["https://openalex.org/I19630809"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5073550160","display_name":"Silvio K. Garattini","orcid":"https://orcid.org/0000-0003-0647-9297","observed_orcids":["https://orcid.org/0000-0003-0647-9297"]},"institutions":[{"id":"https://openalex.org/I19630809","display_name":"Mario Negri Institute for Pharmacological Research","ror":"https://ror.org/05aspc753","country_code":"IT","type":"nonprofit","lineage":["https://openalex.org/I19630809","https://openalex.org/I4210110338","https://openalex.org/I4210153126"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"Silvio Garattini","raw_affiliation_strings":["Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157, Milano, Italy","Istituto di Ricerche Farmacologiche \u2018Mario Negri\u2019, Milano, (Italy)"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Istituto di Ricerche Farmacologiche Mario Negri, Via Eritrea 62, 20157, Milano, Italy","institution_ids":["https://openalex.org/I19630809"]},{"raw_affiliation_string":"Istituto di Ricerche Farmacologiche \u2018Mario Negri\u2019, Milano, (Italy)","institution_ids":["https://openalex.org/I19630809"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5052679679"],"corresponding_institution_ids":["https://openalex.org/I19630809"],"apc_list":{"value":4990,"currency":"USD","value_usd":4990},"apc_paid":null,"fwci":15.5301,"has_fulltext":false,"cited_by_count":86,"citation_normalized_percentile":{"value":0.98626768,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":88,"max":99},"biblio":{"volume":"19","issue":"2","first_page":"187","last_page":"195"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9990000128746033,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.9990000128746033,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.00019999999494757503,"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/T13117","display_name":"Health Education and Validation","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2922","display_name":"Research and Theory"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/health-related-quality-of-life","display_name":"health-related quality of life","score":1.0},{"id":"https://openalex.org/keywords/regulatory-assessment","display_name":"regulatory evaluation","score":0.43799999356269836},{"id":"https://openalex.org/keywords/quality-of-life-outcomes","display_name":"quality of life outcomes","score":0.7070000171661377},{"id":"https://openalex.org/keywords/psychometric-measures","display_name":"psychometric measures","score":0.6200000047683716},{"id":"https://openalex.org/keywords/regulatory-recommendations","display_name":"regulatory recommendations","score":0.45399999618530273},{"id":"https://openalex.org/keywords/fda-guidance","display_name":"FDA guidance","score":0.7710000276565552},{"id":"https://openalex.org/keywords/drug-approval","display_name":"drug approval","score":0.34200000762939453},{"id":"https://openalex.org/keywords/trial-design","display_name":"trial design","score":0.6190000176429749}],"concepts":[{"id":"https://openalex.org/C547195049","wikidata":"https://www.wikidata.org/wiki/Q1725664","display_name":"Terminology","level":2,"score":0.7306715846061707},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5744264721870422},{"id":"https://openalex.org/C108170787","wikidata":"https://www.wikidata.org/wiki/Q3951828","display_name":"Agency (philosophy)","level":2,"score":0.5394018888473511},{"id":"https://openalex.org/C2779951463","wikidata":"https://www.wikidata.org/wiki/Q7268788","display_name":"Quality of life (healthcare)","level":2,"score":0.5253735780715942},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.472494512796402},{"id":"https://openalex.org/C137992405","wikidata":"https://www.wikidata.org/wiki/Q1137608","display_name":"Health administration","level":3,"score":0.4436941146850586},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.4282936453819275},{"id":"https://openalex.org/C138816342","wikidata":"https://www.wikidata.org/wiki/Q189603","display_name":"Public health","level":2,"score":0.40863507986068726},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.32123100757598877},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.22754979133605957},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.1623460352420807},{"id":"https://openalex.org/C144024400","wikidata":"https://www.wikidata.org/wiki/Q21201","display_name":"Sociology","level":0,"score":0.09553062915802002},{"id":"https://openalex.org/C36289849","wikidata":"https://www.wikidata.org/wiki/Q34749","display_name":"Social science","level":1,"score":0.0},{"id":"https://openalex.org/C41895202","wikidata":"https://www.wikidata.org/wiki/Q8162","display_name":"Linguistics","level":1,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.0},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D005062","descriptor_name":"European Union","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":"D011788","descriptor_name":"Quality of Life","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true},{"descriptor_ui":"D017277","descriptor_name":"Drug Approval","qualifier_ui":"Q000331","qualifier_name":"legislation & jurisprudence","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.2165/00019053-200119020-00005","doi":"https://doi.org/10.2165/00019053-200119020-00005","is_oa":false,"landing_page_url":"https://doi.org/10.2165/00019053-200119020-00005","pdf_url":null,"source":{"id":"https://openalex.org/S43019230","display_name":"PharmacoEconomics","issn_l":"1170-7690","issn":["1170-7690","1179-2027"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-c","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320330","host_organization_name":"Adis, Springer Healthcare","host_organization_lineage":["https://openalex.org/P4310320330","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Adis, Springer Healthcare","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"PharmacoEconomics","raw_type":"journal-article"},{"id":"pmid:11284382","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/11284382","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":"PharmacoEconomics","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.9537000060081482,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320306606","display_name":"American Thoracic Society","ror":"https://ror.org/0547sz392"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":30,"referenced_works":["https://openalex.org/W228126680","https://openalex.org/W1493773294","https://openalex.org/W1519667195","https://openalex.org/W1606460755","https://openalex.org/W1657562951","https://openalex.org/W1749929752","https://openalex.org/W1975207098","https://openalex.org/W1978774738","https://openalex.org/W1987445308","https://openalex.org/W1989528006","https://openalex.org/W1993415002","https://openalex.org/W2013700562","https://openalex.org/W2015497941","https://openalex.org/W2031065729","https://openalex.org/W2043445373","https://openalex.org/W2046694319","https://openalex.org/W2054230565","https://openalex.org/W2062581042","https://openalex.org/W2062885735","https://openalex.org/W2068141984","https://openalex.org/W2079927770","https://openalex.org/W2081815965","https://openalex.org/W2103273466","https://openalex.org/W2113971413","https://openalex.org/W2125985143","https://openalex.org/W2335592397","https://openalex.org/W2601846828","https://openalex.org/W3112583453","https://openalex.org/W4246147341","https://openalex.org/W4301504465"],"related_works":["https://openalex.org/W2109437062","https://openalex.org/W2142713918","https://openalex.org/W2090432028","https://openalex.org/W132947955","https://openalex.org/W2099563036","https://openalex.org/W2002926751","https://openalex.org/W1982131526","https://openalex.org/W2313416248","https://openalex.org/W2081491699","https://openalex.org/W2024038683"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":4},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":2},{"year":2021,"cited_by_count":7},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":4},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":3},{"year":2016,"cited_by_count":4},{"year":2015,"cited_by_count":6},{"year":2014,"cited_by_count":1},{"year":2013,"cited_by_count":3},{"year":2012,"cited_by_count":7}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2016-06-24T00:00:00"}
