{"id":"https://openalex.org/W1977938996","doi":"https://doi.org/10.1080/09537320123087","title":"The Changing Landscape of Regulatory Control of Biological Medicines","display_name":"The Changing Landscape of Regulatory Control of Biological Medicines","publication_year":2001,"publication_date":"2001-06-01","ids":{"openalex":"https://openalex.org/W1977938996","doi":"https://doi.org/10.1080/09537320123087","mag":"1977938996"},"language":"en","primary_location":{"id":"doi:10.1080/09537320123087","is_oa":false,"landing_page_url":"https://doi.org/10.1080/09537320123087","pdf_url":null,"source":{"id":"https://openalex.org/S130699561","display_name":"Technology Analysis and Strategic Management","issn_l":"0953-7325","issn":["0953-7325","1465-3990"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Technology Analysis & Strategic Management","raw_type":"journal-article"},"type":"article","indexed_in":["crossref"],"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/A5041604366","display_name":"Norma Morris","orcid":null},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Norma Morris","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5041604366"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.3716,"has_fulltext":false,"cited_by_count":4,"citation_normalized_percentile":{"value":0.67716472,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"13","issue":"2","first_page":"247","last_page":"263"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T14293","display_name":"Biotechnology and Related Fields","score":0.9962999820709229,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T14293","display_name":"Biotechnology and Related Fields","score":0.9962999820709229,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9937000274658203,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.9937000274658203,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"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/harmonization","display_name":"Harmonization","score":0.7097457647323608},{"id":"https://openalex.org/keywords/general-partnership","display_name":"General partnership","score":0.6558082103729248},{"id":"https://openalex.org/keywords/quality","display_name":"Quality (philosophy)","score":0.5836066603660583},{"id":"https://openalex.org/keywords/control","display_name":"Control (management)","score":0.5206810235977173},{"id":"https://openalex.org/keywords/business","display_name":"Business","score":0.4671957492828369},{"id":"https://openalex.org/keywords/devolution","display_name":"Devolution (biology)","score":0.44703733921051025},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.3324686884880066},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.1402885615825653},{"id":"https://openalex.org/keywords/management","display_name":"Management","score":0.13470041751861572},{"id":"https://openalex.org/keywords/economics","display_name":"Economics","score":0.12903809547424316}],"concepts":[{"id":"https://openalex.org/C2779962950","wikidata":"https://www.wikidata.org/wiki/Q5659376","display_name":"Harmonization","level":2,"score":0.7097457647323608},{"id":"https://openalex.org/C71750763","wikidata":"https://www.wikidata.org/wiki/Q646164","display_name":"General partnership","level":2,"score":0.6558082103729248},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.5836066603660583},{"id":"https://openalex.org/C2775924081","wikidata":"https://www.wikidata.org/wiki/Q55608371","display_name":"Control (management)","level":2,"score":0.5206810235977173},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4671957492828369},{"id":"https://openalex.org/C190542761","wikidata":"https://www.wikidata.org/wiki/Q904637","display_name":"Devolution (biology)","level":3,"score":0.44703733921051025},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.3324686884880066},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.1402885615825653},{"id":"https://openalex.org/C187736073","wikidata":"https://www.wikidata.org/wiki/Q2920921","display_name":"Management","level":1,"score":0.13470041751861572},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.12903809547424316},{"id":"https://openalex.org/C10138342","wikidata":"https://www.wikidata.org/wiki/Q43015","display_name":"Finance","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},{"id":"https://openalex.org/C143733281","wikidata":"https://www.wikidata.org/wiki/Q372949","display_name":"Bipedalism","level":2,"score":0.0},{"id":"https://openalex.org/C105702510","wikidata":"https://www.wikidata.org/wiki/Q514","display_name":"Anatomy","level":1,"score":0.0},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.0},{"id":"https://openalex.org/C24890656","wikidata":"https://www.wikidata.org/wiki/Q82811","display_name":"Acoustics","level":1,"score":0.0}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1080/09537320123087","is_oa":false,"landing_page_url":"https://doi.org/10.1080/09537320123087","pdf_url":null,"source":{"id":"https://openalex.org/S130699561","display_name":"Technology Analysis and Strategic Management","issn_l":"0953-7325","issn":["0953-7325","1465-3990"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310320547","host_organization_name":"Taylor & Francis","host_organization_lineage":["https://openalex.org/P4310320547","https://openalex.org/P4310320449"],"host_organization_lineage_names":["Taylor & Francis","Informa"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Technology Analysis & Strategic Management","raw_type":"journal-article"},{"id":"pmh:oai:eprints.ucl.ac.uk.OAI2:81765","is_oa":false,"landing_page_url":"http://discovery.ucl.ac.uk/81765/","pdf_url":null,"source":{"id":"https://openalex.org/S4306400024","display_name":"UCL Discovery (University College London)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I45129253","host_organization_name":"University College London","host_organization_lineage":["https://openalex.org/I45129253"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Technology Analysis and Strategic Management , 13 (2) pp. 247-263. (2001)","raw_type":"Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/17","score":0.44999998807907104,"display_name":"Partnerships for the goals"},{"id":"https://metadata.un.org/sdg/9","score":0.41999998688697815,"display_name":"Industry, innovation and infrastructure"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320332167","display_name":"Directorate for Biological Sciences","ror":"https://ror.org/001xhss06"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":23,"referenced_works":["https://openalex.org/W235873423","https://openalex.org/W347992402","https://openalex.org/W393979507","https://openalex.org/W632868732","https://openalex.org/W1927338452","https://openalex.org/W1976412301","https://openalex.org/W1977217860","https://openalex.org/W1977563467","https://openalex.org/W1990423055","https://openalex.org/W2007177261","https://openalex.org/W2013421340","https://openalex.org/W2022709494","https://openalex.org/W2099649939","https://openalex.org/W2159975576","https://openalex.org/W2247528315","https://openalex.org/W2297789379","https://openalex.org/W2401490852","https://openalex.org/W2417007242","https://openalex.org/W2444495897","https://openalex.org/W2462142173","https://openalex.org/W3126004753","https://openalex.org/W3186861947","https://openalex.org/W4214713083"],"related_works":["https://openalex.org/W2006073222","https://openalex.org/W1549971518","https://openalex.org/W2001095545","https://openalex.org/W2488916264","https://openalex.org/W2613095406","https://openalex.org/W1548030735","https://openalex.org/W1526226136","https://openalex.org/W3158345302","https://openalex.org/W2323573032","https://openalex.org/W2106193995"],"abstract_inverted_index":{"This":[0],"paper":[1],"focuses":[2],"on":[3,105],"the":[4,27,46,54,95],"rapid":[5],"growth":[6],"in":[7,10,17,44,51,67,87],"biological":[8],"medicines":[9],"recent":[11],"years":[12],"brought":[13],"about":[14],"by":[15,117],"advances":[16],"molecular":[18],"biology":[19],"and":[20,32,41,108,113,120],"biotechnological":[21],"manufacturing":[22],"techniques.":[23],"It":[24,57],"looks":[25],"at":[26],"implications":[28],"for":[29,98],"regulatory":[30,71],"bodies":[31],"research":[33,104],"institutions":[34],"concerned":[35],"with":[36],"quality":[37,100],"control":[38,72],"of":[39,70,77,94],"biologicals;":[40],"discusses":[42],"ways":[43],"which":[45],"industry/regulatory/research":[47],"partnership":[48],"is":[49,62],"evolving":[50],"response":[52],"to":[53,74],"new":[55,78,118],"situation.":[56],"argues":[58],"that,":[59],"although":[60],"change":[61],"being":[63],"managed":[64],"relatively":[65],"successfully":[66],"some":[68,88],"areas":[69],"(devolution":[73],"industry,":[75],"use":[76],"technologies,":[79],"international":[80],"harmonization),":[81],"special":[82],"measures":[83],"may":[84],"be":[85],"needed":[86],"other":[89],"areas.":[90],"These":[91],"include:":[92],"needs":[93],"developing":[96],"world":[97],"biologicals":[99],"control;":[101],"sustaining":[102],"long-term":[103],"safety":[106],"issues":[107,115],"test":[109],"methodology;":[110],"major":[111],"social":[112],"ethical":[114],"raised":[116],"treatment":[119],"diagnostic":[121],"opportunities.":[122]},"counts_by_year":[],"updated_date":"2026-08-15T07:11:24.734988","created_date":"2025-10-10T00:00:00"}