{"id":"https://openalex.org/W2534371925","doi":"https://doi.org/10.1016/j.toxlet.2016.07.707","title":"Are in vivo studies needed in the safety assessment of biosimilars? A regulatory perspective","display_name":"Are in vivo studies needed in the safety assessment of biosimilars? A regulatory perspective","publication_year":2016,"publication_date":"2016-10-01","ids":{"openalex":"https://openalex.org/W2534371925","doi":"https://doi.org/10.1016/j.toxlet.2016.07.707","mag":"2534371925"},"language":"en","primary_location":{"id":"doi:10.1016/j.toxlet.2016.07.707","doi":"https://doi.org/10.1016/j.toxlet.2016.07.707","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.toxlet.2016.07.707","pdf_url":null,"source":{"id":"https://openalex.org/S205878144","display_name":"Toxicology Letters","issn_l":"0378-4274","issn":["0378-4274","1879-3169"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Toxicology Letters","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"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/A5035530012","display_name":"Leon van Aerts","orcid":"https://orcid.org/0000-0002-0025-0099","observed_orcids":["https://orcid.org/0000-0002-0025-0099"]},"institutions":[{"id":"https://openalex.org/I4210150351","display_name":"Medicines Evaluation Board","ror":"https://ror.org/05mv4rb84","country_code":"NL","type":"education","lineage":["https://openalex.org/I4210150351"]}],"countries":["NL"],"is_corresponding":true,"raw_author_name":"L. van Aerts","raw_affiliation_strings":["Department of Pharmacology, Toxicology and Pharmacokinetics, Medicines Evaluation Board, Utrecht, The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology, Toxicology and Pharmacokinetics, Medicines Evaluation Board, Utrecht, The Netherlands","institution_ids":["https://openalex.org/I4210150351"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5035530012"],"corresponding_institution_ids":["https://openalex.org/I4210150351"],"apc_list":{"value":4270,"currency":"USD","value_usd":4270},"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"259","issue":null,"first_page":"S23","last_page":"S23"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.986299991607666,"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"}},"topics":[{"id":"https://openalex.org/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.986299991607666,"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/T12281","display_name":"Animal testing and alternatives","score":0.0035000001080334187,"subfield":{"id":"https://openalex.org/subfields/3404","display_name":"Small Animals"},"field":{"id":"https://openalex.org/fields/34","display_name":"Veterinary"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.0010000000474974513,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":0.9900000095367432},{"id":"https://openalex.org/keywords/in-vivo-evaluation","display_name":"in vivo evaluation","score":0.7540000081062317},{"id":"https://openalex.org/keywords/safety-assessment","display_name":"safety assessment","score":0.9430000185966492},{"id":"https://openalex.org/keywords/regulatory-requirements","display_name":"regulatory requirements","score":0.6460000276565552},{"id":"https://openalex.org/keywords/hydrolysis-kinetics","display_name":"hydrolysis kinetics","score":0.8420000076293945},{"id":"https://openalex.org/keywords/polysilsesquioxane","display_name":"polysilsesquioxane","score":0.906000018119812},{"id":"https://openalex.org/keywords/sol-gel-reaction","display_name":"sol-gel reaction","score":0.8790000081062317},{"id":"https://openalex.org/keywords/hydrolysis-and-polycondensation","display_name":"hydrolysis and polycondensation","score":0.9459999799728394},{"id":"https://openalex.org/keywords/organosilane-precursors","display_name":"organosilane precursors","score":0.8379999995231628},{"id":"https://openalex.org/keywords/molecular-weight","display_name":"molecular weight","score":0.7149999737739563},{"id":"https://openalex.org/keywords/degree-of-condensation","display_name":"degree of condensation","score":0.9900000095367432}],"concepts":[{"id":"https://openalex.org/C94412978","wikidata":"https://www.wikidata.org/wiki/Q103135","display_name":"Hydrolysis","level":2,"score":0.7940114736557007},{"id":"https://openalex.org/C166940927","wikidata":"https://www.wikidata.org/wiki/Q178827","display_name":"Monomer","level":3,"score":0.7015555500984192},{"id":"https://openalex.org/C2780471494","wikidata":"https://www.wikidata.org/wiki/Q146505","display_name":"Solvent","level":2,"score":0.6366979479789734},{"id":"https://openalex.org/C53033327","wikidata":"https://www.wikidata.org/wiki/Q2371697","display_name":"Condensation polymer","level":3,"score":0.6247636079788208},{"id":"https://openalex.org/C200093464","wikidata":"https://www.wikidata.org/wiki/Q166583","display_name":"Condensation","level":2,"score":0.6155068278312683},{"id":"https://openalex.org/C184651966","wikidata":"https://www.wikidata.org/wiki/Q906356","display_name":"Aqueous solution","level":2,"score":0.5860812664031982},{"id":"https://openalex.org/C59491497","wikidata":"https://www.wikidata.org/wiki/Q864715","display_name":"Biosimilar","level":2,"score":0.5601537227630615},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.5582089424133301},{"id":"https://openalex.org/C148898269","wikidata":"https://www.wikidata.org/wiki/Q1108792","display_name":"Kinetics","level":2,"score":0.5032753348350525},{"id":"https://openalex.org/C188027245","wikidata":"https://www.wikidata.org/wiki/Q750446","display_name":"Polymer chemistry","level":1,"score":0.39939409494400024},{"id":"https://openalex.org/C42360764","wikidata":"https://www.wikidata.org/wiki/Q83588","display_name":"Chemical engineering","level":1,"score":0.372978150844574},{"id":"https://openalex.org/C178790620","wikidata":"https://www.wikidata.org/wiki/Q11351","display_name":"Organic chemistry","level":1,"score":0.3099533021450043},{"id":"https://openalex.org/C161790260","wikidata":"https://www.wikidata.org/wiki/Q82264","display_name":"Catalysis","level":2,"score":0.2763780355453491},{"id":"https://openalex.org/C521977710","wikidata":"https://www.wikidata.org/wiki/Q81163","display_name":"Polymer","level":2,"score":0.16456368565559387},{"id":"https://openalex.org/C97355855","wikidata":"https://www.wikidata.org/wiki/Q11473","display_name":"Thermodynamics","level":1,"score":0.148758202791214},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"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/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.0},{"id":"https://openalex.org/C62520636","wikidata":"https://www.wikidata.org/wiki/Q944","display_name":"Quantum mechanics","level":1,"score":0.0},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1016/j.toxlet.2016.07.707","doi":"https://doi.org/10.1016/j.toxlet.2016.07.707","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.toxlet.2016.07.707","pdf_url":null,"source":{"id":"https://openalex.org/S205878144","display_name":"Toxicology Letters","issn_l":"0378-4274","issn":["0378-4274","1879-3169"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Toxicology Letters","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2514193360","https://openalex.org/W2304989811","https://openalex.org/W2043830752","https://openalex.org/W2324430094","https://openalex.org/W3033778131","https://openalex.org/W2377946392","https://openalex.org/W2331478939","https://openalex.org/W1971219066","https://openalex.org/W2006759790","https://openalex.org/W2043431490"],"abstract_inverted_index":null,"counts_by_year":[],"updated_date":"2026-11-06T12:05:46.655746","created_date":"2016-10-28T00:00:00"}