{"id":"https://openalex.org/W2946922834","doi":"https://doi.org/10.1080/19466315.2018.1555097","title":"Multivariate Mixed-Effects Kinetic Models for Multiple Correlated Quality Attributes From Accelerated Stability Studies","display_name":"Multivariate Mixed-Effects Kinetic Models for Multiple Correlated Quality Attributes From Accelerated Stability Studies","publication_year":2019,"publication_date":"2019-04-03","ids":{"openalex":"https://openalex.org/W2946922834","doi":"https://doi.org/10.1080/19466315.2018.1555097","mag":"2946922834"},"language":"en","primary_location":{"id":"doi:10.1080/19466315.2018.1555097","doi":"https://doi.org/10.1080/19466315.2018.1555097","is_oa":false,"landing_page_url":"https://doi.org/10.1080/19466315.2018.1555097","pdf_url":null,"source":{"id":"https://openalex.org/S104563881","display_name":"Statistics in Biopharmaceutical Research","issn_l":"1946-6315","issn":["1946-6315"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","ki-jl-1","norway-1","poland-100","russia-white-list-2","vabb-shw"],"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":"Statistics in Biopharmaceutical Research","raw_type":"journal-article"},"volume":null,"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/A5032118390","display_name":"Binbing Yu","orcid":"https://orcid.org/0000-0003-3647-5852","observed_orcids":["https://orcid.org/0000-0003-3647-5852"]},"institutions":[{"id":"https://openalex.org/I4210150756","display_name":"AstraZeneca (United States)","ror":"https://ror.org/043cec594","country_code":"US","type":"company","lineage":["https://openalex.org/I105036370","https://openalex.org/I4210150756"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Binbing Yu","raw_affiliation_strings":["Statistical Sciences, AstraZeneca Oncology Biometrics, Gaithersburg, MD"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Statistical Sciences, AstraZeneca Oncology Biometrics, Gaithersburg, MD","institution_ids":["https://openalex.org/I4210150756"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5113917094","display_name":"Lingmin Zeng","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210150756","display_name":"AstraZeneca (United States)","ror":"https://ror.org/043cec594","country_code":"US","type":"company","lineage":["https://openalex.org/I105036370","https://openalex.org/I4210150756"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lingmin Zeng","raw_affiliation_strings":["Statistical Sciences, AstraZeneca Oncology Biometrics, Gaithersburg, MD"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Statistical Sciences, AstraZeneca Oncology Biometrics, Gaithersburg, MD","institution_ids":["https://openalex.org/I4210150756"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5020601958","display_name":"Harry Yang","orcid":"https://orcid.org/0009-0008-8758-5705","observed_orcids":["https://orcid.org/0009-0008-8758-5705"]},"institutions":[{"id":"https://openalex.org/I4210150756","display_name":"AstraZeneca (United States)","ror":"https://ror.org/043cec594","country_code":"US","type":"company","lineage":["https://openalex.org/I105036370","https://openalex.org/I4210150756"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Harry Yang","raw_affiliation_strings":["Statistical Sciences, AstraZeneca Oncology Biometrics, Gaithersburg, MD"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Statistical Sciences, AstraZeneca Oncology Biometrics, Gaithersburg, MD","institution_ids":["https://openalex.org/I4210150756"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5032118390"],"corresponding_institution_ids":["https://openalex.org/I4210150756"],"apc_list":null,"apc_paid":null,"fwci":0.1402,"has_fulltext":false,"cited_by_count":3,"citation_normalized_percentile":{"value":0.379273,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":96},"biblio":{"volume":"11","issue":"2","first_page":"175","last_page":"181"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.6122999787330627,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.6122999787330627,"subfield":{"id":"https://openalex.org/subfields/1602","display_name":"Analytical Chemistry"},"field":{"id":"https://openalex.org/fields/16","display_name":"Chemistry"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.08290000259876251,"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/T11124","display_name":"Protein purification and stability","score":0.07010000199079514,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/accelerated-stability-testing","display_name":"accelerated stability testing","score":0.8899999856948853},{"id":"https://openalex.org/keywords/degradation-kinetics","display_name":"degradation kinetics","score":0.8709999918937683},{"id":"https://openalex.org/keywords/arrhenius-equation","display_name":"Arrhenius equation","score":0.8149999976158142},{"id":"https://openalex.org/keywords/critical-quality-attributes","display_name":"critical quality attributes","score":0.8970000147819519},{"id":"https://openalex.org/keywords/lot-to-lot-variability","display_name":"lot-to-lot variation","score":0.9179999828338623},{"id":"https://openalex.org/keywords/random-effects","display_name":"random effects","score":0.8240000009536743},{"id":"https://openalex.org/keywords/therapeutic-proteins","display_name":"therapeutic proteins","score":0.8320000171661377},{"id":"https://openalex.org/keywords/shelf-life-prediction","display_name":"shelf life prediction","score":0.7590000033378601},{"id":"https://openalex.org/keywords/degradation-rate-estimation","display_name":"degradation rate estimation","score":0.5849999785423279}],"concepts":[{"id":"https://openalex.org/C112972136","wikidata":"https://www.wikidata.org/wiki/Q7595718","display_name":"Stability (learning theory)","level":2,"score":0.752906084060669},{"id":"https://openalex.org/C161584116","wikidata":"https://www.wikidata.org/wiki/Q1952580","display_name":"Multivariate statistics","level":2,"score":0.6809015870094299},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.5270191431045532},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.45915666222572327},{"id":"https://openalex.org/C2779679103","wikidata":"https://www.wikidata.org/wiki/Q5251805","display_name":"Degradation (telecommunications)","level":2,"score":0.4590927064418793},{"id":"https://openalex.org/C61797465","wikidata":"https://www.wikidata.org/wiki/Q1188986","display_name":"Term (time)","level":2,"score":0.42468342185020447},{"id":"https://openalex.org/C124101348","wikidata":"https://www.wikidata.org/wiki/Q172491","display_name":"Data mining","level":1,"score":0.4196310043334961},{"id":"https://openalex.org/C149782125","wikidata":"https://www.wikidata.org/wiki/Q160039","display_name":"Econometrics","level":1,"score":0.4141552150249481},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.40750357508659363},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.37690797448158264},{"id":"https://openalex.org/C183696295","wikidata":"https://www.wikidata.org/wiki/Q2487696","display_name":"Biochemical engineering","level":1,"score":0.3674611449241638},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.3334729075431824},{"id":"https://openalex.org/C186060115","wikidata":"https://www.wikidata.org/wiki/Q30336093","display_name":"Biological system","level":1,"score":0.3207319676876068},{"id":"https://openalex.org/C119857082","wikidata":"https://www.wikidata.org/wiki/Q2539","display_name":"Machine learning","level":1,"score":0.20479583740234375},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.1600465476512909},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","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/C62520636","wikidata":"https://www.wikidata.org/wiki/Q944","display_name":"Quantum mechanics","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/C76155785","wikidata":"https://www.wikidata.org/wiki/Q418","display_name":"Telecommunications","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1080/19466315.2018.1555097","doi":"https://doi.org/10.1080/19466315.2018.1555097","is_oa":false,"landing_page_url":"https://doi.org/10.1080/19466315.2018.1555097","pdf_url":null,"source":{"id":"https://openalex.org/S104563881","display_name":"Statistics in Biopharmaceutical Research","issn_l":"1946-6315","issn":["1946-6315"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","ki-jl-1","norway-1","poland-100","russia-white-list-2","vabb-shw"],"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":"Statistics in Biopharmaceutical Research","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":38,"referenced_works":["https://openalex.org/W1417840079","https://openalex.org/W1549853756","https://openalex.org/W1614468563","https://openalex.org/W1970187689","https://openalex.org/W1975714885","https://openalex.org/W1976164372","https://openalex.org/W1982829395","https://openalex.org/W1984854392","https://openalex.org/W1987162662","https://openalex.org/W1991856396","https://openalex.org/W2011260590","https://openalex.org/W2011679445","https://openalex.org/W2013133034","https://openalex.org/W2014464028","https://openalex.org/W2018522840","https://openalex.org/W2020783305","https://openalex.org/W2045656233","https://openalex.org/W2046027112","https://openalex.org/W2051524692","https://openalex.org/W2062872999","https://openalex.org/W2066537571","https://openalex.org/W2076777909","https://openalex.org/W2082746669","https://openalex.org/W2083114435","https://openalex.org/W2089828431","https://openalex.org/W2100697453","https://openalex.org/W2134012062","https://openalex.org/W2148534890","https://openalex.org/W2152090448","https://openalex.org/W2483500811","https://openalex.org/W2580793072","https://openalex.org/W2582743722","https://openalex.org/W3098336475","https://openalex.org/W4200277733","https://openalex.org/W4212767417","https://openalex.org/W4237545981","https://openalex.org/W4243350943","https://openalex.org/W4285719527"],"related_works":["https://openalex.org/W2068561015","https://openalex.org/W2473047286","https://openalex.org/W2066537571","https://openalex.org/W7203532302","https://openalex.org/W3211221264","https://openalex.org/W2023602904","https://openalex.org/W2009861999","https://openalex.org/W4211188730","https://openalex.org/W2432426385","https://openalex.org/W2061256746"],"abstract_inverted_index":{"Stability":[0],"study":[1],"is":[2],"a":[3,13,141,209],"critical":[4,76,121],"component":[5],"for":[6,69,81,208,214],"the":[7,26,33,48,62,83,89,110,150,173,177,198],"submission":[8],"and":[9,29,45,52,65,73,86,152,159,163],"market":[10],"authorization":[11],"of":[12,32,50,75,88,136,176,185,204],"new":[14],"drug":[15,34,137],"or":[16],"biological":[17],"product.":[18,35],"Long-term":[19],"stability":[20,27,37,55,102,106,154,202],"studies":[21,38,56,170],"are":[22,57,79,123,128,133,212],"required":[23],"to":[24,60,99,108,196],"establish":[25],"profile":[28],"shelf":[30],"life":[31],"Accelerated":[36,54],"may":[39,180,191],"provide":[40,181,192],"insight":[41,193],"into":[42],"degradation":[43,111,186],"pathways":[44],"help":[46],"expedite":[47],"development":[49],"formulation":[51],"packaging.":[53],"also":[58],"useful":[59],"identify":[61],"stability-indicating":[63,120,199],"attributes":[64,78,122,127,179,207],"appropriate":[66],"assay":[67],"methods":[68],"measuring":[70],"degradation.":[71],"Selection":[72],"specifications":[74],"quality":[77,206],"imperative":[80],"ensuring":[82],"quality,":[84],"safety,":[85],"efficacy":[87],"drug.":[90],"For":[91],"individual":[92],"attributes,":[93],"Arrhenius":[94,157],"equation":[95,158],"has":[96],"been":[97],"used":[98],"combine":[100,149],"accelerated":[101,151],"data":[103,107,155,203],"with":[104,166],"long-term":[105,114,153],"predict":[109],"rates":[112],"under":[113],"storage":[115],"conditions.":[116],"In":[117],"practice,":[118],"multiple":[119,126],"available.":[124],"The":[125,188,201],"intrinsically":[129],"correlated":[130,178],"because":[131],"they":[132],"all":[134],"indicators":[135],"quality.":[138],"We":[139],"propose":[140],"multivariate":[142,174],"mixed-effects":[143],"kinetic":[144],"model,":[145],"which":[146],"can":[147],"both":[148],"using":[156],"incorporate":[160],"lot-to-lot":[161],"variability":[162],"between-attribute":[164],"correlations":[165],"random":[167],"effects.":[168],"Simulation":[169],"show":[171],"that":[172],"modeling":[175],"more":[182],"accurate":[183],"estimates":[184],"rates.":[187],"proposed":[189],"model":[190],"on":[194],"how":[195],"select":[197],"attributes.":[200],"three":[205],"therapeutic":[210],"protein":[211],"analyzed":[213],"illustration.":[215]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":1}],"updated_date":"2026-10-14T16:39:01.820549","created_date":"2019-06-07T00:00:00"}
