{"id":"https://openalex.org/W2353733403","doi":null,"title":"Statistical approaches to establishing bioequivalence","display_name":"Statistical approaches to establishing bioequivalence","publication_year":2004,"publication_date":"2004-01-01","ids":{"openalex":"https://openalex.org/W2353733403","mag":"2353733403"},"language":"en","primary_location":{"id":"mag:2353733403","doi":null,"is_oa":false,"landing_page_url":"https://en.cnki.com.cn/Article_en/CJFDTOTAL-YLZL200408027.htm","pdf_url":null,"source":{"id":"https://openalex.org/S2764721185","display_name":"Zhongguo linchuang yaolixue yu zhiliaoxue","issn_l":"1009-2501","issn":["1009-2501"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4361727491","host_organization_name":"Chinese Pharmacological Society","host_organization_lineage":["https://openalex.org/P4361727491"],"host_organization_lineage_names":["Chinese Pharmacological Society"],"type":"journal"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"Zhongguo linchuang yaolixue yu zhiliaoxue","raw_type":null},"volume":null,"type":"article","is_traditional":true,"indexed_in":[],"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/A5102215272","display_name":"Lu Jing","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2799773085","display_name":"Nanjing General Hospital of Nanjing Military Command","ror":"https://ror.org/04kmpyd03","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I2799773085"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Lu Jing","raw_affiliation_strings":["2 Department of Technology, Nanjing Military General Hospital,Nanjing 210020, Jiangsu, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"2 Department of Technology, Nanjing Military General Hospital,Nanjing 210020, Jiangsu, China","institution_ids":["https://openalex.org/I2799773085"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5102215272"],"corresponding_institution_ids":["https://openalex.org/I2799773085"],"apc_list":null,"apc_paid":null,"fwci":9.9539,"has_fulltext":false,"cited_by_count":206,"citation_normalized_percentile":{"value":0.98657003,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":97,"max":100},"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9901999831199646,"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":0.9901999831199646,"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/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.004000000189989805,"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/T12547","display_name":"Pharmaceutical studies and practices","score":0.0038999998942017555,"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/bioequivalence","display_name":"bioequivalence","score":0.9909999966621399},{"id":"https://openalex.org/keywords/average-bioequivalence","display_name":"average bioequivalence","score":0.953000009059906},{"id":"https://openalex.org/keywords/population-bioequivalence","display_name":"population bioequivalence","score":1.0},{"id":"https://openalex.org/keywords/individual-bioequivalence","display_name":"individual bioequivalence","score":1.0},{"id":"https://openalex.org/keywords/bioavailability","display_name":"bioavailability","score":0.7609999775886536},{"id":"https://openalex.org/keywords/therapeutic-equivalence","display_name":"therapeutic equivalence","score":0.6359999775886536},{"id":"https://openalex.org/keywords/intra-individual-variability","display_name":"within-person variability","score":0.8259999752044678},{"id":"https://openalex.org/keywords/statistical-criteria","display_name":"statistical criteria","score":0.5040000081062317}],"concepts":[{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.9740190505981445},{"id":"https://openalex.org/C2780069185","wikidata":"https://www.wikidata.org/wiki/Q7977945","display_name":"Equivalence (formal languages)","level":2,"score":0.6974873542785645},{"id":"https://openalex.org/C2780009758","wikidata":"https://www.wikidata.org/wiki/Q6804172","display_name":"Measure (data warehouse)","level":2,"score":0.6078163981437683},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.588172972202301},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.5437260270118713},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.5299329161643982},{"id":"https://openalex.org/C149782125","wikidata":"https://www.wikidata.org/wiki/Q160039","display_name":"Econometrics","level":1,"score":0.5005688667297363},{"id":"https://openalex.org/C181389837","wikidata":"https://www.wikidata.org/wiki/Q461809","display_name":"Bioavailability","level":2,"score":0.43322426080703735},{"id":"https://openalex.org/C87007009","wikidata":"https://www.wikidata.org/wiki/Q210832","display_name":"Statistical hypothesis testing","level":2,"score":0.4136124849319458},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.22570598125457764},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.2240721881389618},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.13374477624893188},{"id":"https://openalex.org/C124101348","wikidata":"https://www.wikidata.org/wiki/Q172491","display_name":"Data mining","level":1,"score":0.11090672016143799},{"id":"https://openalex.org/C118615104","wikidata":"https://www.wikidata.org/wiki/Q121416","display_name":"Discrete mathematics","level":1,"score":0.0},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"mag:2353733403","doi":null,"is_oa":false,"landing_page_url":"https://en.cnki.com.cn/Article_en/CJFDTOTAL-YLZL200408027.htm","pdf_url":null,"source":{"id":"https://openalex.org/S2764721185","display_name":"Zhongguo linchuang yaolixue yu zhiliaoxue","issn_l":"1009-2501","issn":["1009-2501"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core"],"host_organization":"https://openalex.org/P4361727491","host_organization_name":"Chinese Pharmacological Society","host_organization_lineage":["https://openalex.org/P4361727491"],"host_organization_lineage_names":["Chinese Pharmacological Society"],"type":"journal"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"Zhongguo linchuang yaolixue yu zhiliaoxue","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.5683000087738037,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":22,"referenced_works":["https://openalex.org/W76207787","https://openalex.org/W181566260","https://openalex.org/W1978942896","https://openalex.org/W1995945562","https://openalex.org/W2004386213","https://openalex.org/W2017834453","https://openalex.org/W2030890732","https://openalex.org/W2037698344","https://openalex.org/W2044291706","https://openalex.org/W2044402529","https://openalex.org/W2072030385","https://openalex.org/W2080913272","https://openalex.org/W2093027426","https://openalex.org/W2094482736","https://openalex.org/W2117359554","https://openalex.org/W2124889282","https://openalex.org/W2133769904","https://openalex.org/W2320712096","https://openalex.org/W2322666687","https://openalex.org/W2328270446","https://openalex.org/W2410060119","https://openalex.org/W2417309411"],"related_works":["https://openalex.org/W2041244457","https://openalex.org/W2503283136","https://openalex.org/W2049023636","https://openalex.org/W204359187","https://openalex.org/W659270208","https://openalex.org/W4220832872","https://openalex.org/W143548857","https://openalex.org/W34452665","https://openalex.org/W3086823338","https://openalex.org/W1500166058"],"abstract_inverted_index":{"The":[0,44,95],"purpose":[1],"of":[2,31,52,55,59,66,87,92,101,144],"bioequivalence":[3,35,38,42],"(BE)":[4],"trial":[5],"is":[6],"to":[7,79,148,153],"show":[8,24],"that":[9,126],"the":[10,14,50,64,67,70,77,85,93,102,105,108,115,123,128,131,142,145,151],"test":[11],"(T)":[12],"and":[13,22,40,61,72,82,90,117,134,156,161],"reference":[15],"(R)":[16],"products":[17],"can":[18],"produce":[19],"similarity":[20],"bioavailability,":[21],"then":[23],"therapeutically":[25],"equivalence.":[26],"There":[27],"are":[28],"three":[29],"types":[30],"bioequivalence,":[32],"namely,":[33],"average":[34,132],"(ABE),":[36],"population":[37,53],"(PBE)":[39],"individual":[41],"(IBE).":[43],"ABE":[45],"approach":[46,97,110],"focuses":[47],"only":[48],"on":[49,63],"comparison":[51],"averages":[54,89],"a":[56],"BE":[57,157],"measure":[58,68,103],"interest":[60],"not":[62],"variances":[65,91],"for":[69,114],"T":[71,116,133],"R":[73,118,135],"products.":[74],"In":[75,139],"contrast,":[76],"approaches":[78,147],"establish":[80,149],"PBE":[81,96],"IBE":[83,109],"include":[84],"comparisons":[86],"both":[88],"measure.":[94],"assesses":[98,111],"total":[99],"variability":[100,113],"in":[104,130],"population.":[106],"While":[107],"within-subject":[112],"products,":[119],"as":[120,122],"well":[121],"subject-by-formulation":[124],"interaction,":[125],"is,":[127],"variation":[129],"difference":[136],"among":[137],"individuals.":[138],"present":[140],"paper,":[141],"principle":[143],"statistical":[146],"BE,":[150],"way":[152],"predetermine":[154],"criterions":[155],"limits":[158],"were":[159,164],"introduced,":[160],"an":[162],"example":[163],"illustrated.":[165]},"counts_by_year":[{"year":2025,"cited_by_count":4},{"year":2024,"cited_by_count":6},{"year":2023,"cited_by_count":11},{"year":2022,"cited_by_count":9},{"year":2021,"cited_by_count":11},{"year":2020,"cited_by_count":8},{"year":2019,"cited_by_count":6},{"year":2018,"cited_by_count":4},{"year":2017,"cited_by_count":9},{"year":2016,"cited_by_count":6},{"year":2015,"cited_by_count":11},{"year":2014,"cited_by_count":12},{"year":2013,"cited_by_count":8},{"year":2012,"cited_by_count":19}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2016-06-24T00:00:00"}
