{"id":"https://openalex.org/W2901020484","doi":"https://doi.org/10.1590/s2175-97902018000001006","title":"Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)","display_name":"Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)","publication_year":2018,"publication_date":"2018-11-08","ids":{"openalex":"https://openalex.org/W2901020484","doi":"https://doi.org/10.1590/s2175-97902018000001006","mag":"2901020484"},"language":"en","primary_location":{"id":"doi:10.1590/s2175-97902018000001006","doi":"https://doi.org/10.1590/s2175-97902018000001006","is_oa":true,"landing_page_url":"https://doi.org/10.1590/s2175-97902018000001006","pdf_url":"http://www.scielo.br/pdf/bjps/v54nspe/2175-9790-bjps-54-spe-e01006.pdf","source":{"id":"https://openalex.org/S120884445","display_name":"Brazilian Journal of Pharmaceutical Sciences","issn_l":"1984-8250","issn":["1984-8250","2175-9790"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","poland-40","russia-white-list-3","scielo"],"host_organization":"https://openalex.org/P4310312331","host_organization_name":"University of S\u00e3o Paulo","host_organization_lineage":["https://openalex.org/P4310312331"],"host_organization_lineage_names":["University of S\u00e3o Paulo"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Brazilian Journal of Pharmaceutical Sciences","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"http://www.scielo.br/pdf/bjps/v54nspe/2175-9790-bjps-54-spe-e01006.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5021262704","display_name":"Isa Martins Fukuda","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I17974374","display_name":"Universidade de S\u00e3o Paulo","ror":"https://ror.org/036rp1748","country_code":"BR","type":"education","lineage":["https://openalex.org/I17974374"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Isa Martins Fukuda","raw_affiliation_strings":["University of S\u00e3o Paulo,  Brazil","Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of S\u00e3o Paulo,  Brazil","institution_ids":["https://openalex.org/I17974374"]},{"raw_affiliation_string":"Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil","institution_ids":["https://openalex.org/I17974374"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5046617391","display_name":"Camila Francini Fidelis Pinto","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I17974374","display_name":"Universidade de S\u00e3o Paulo","ror":"https://ror.org/036rp1748","country_code":"BR","type":"education","lineage":["https://openalex.org/I17974374"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Camila Francini Fidelis Pinto","raw_affiliation_strings":["University of S\u00e3o Paulo,  Brazil","Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of S\u00e3o Paulo,  Brazil","institution_ids":["https://openalex.org/I17974374"]},{"raw_affiliation_string":"Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil","institution_ids":["https://openalex.org/I17974374"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5069556797","display_name":"Camila dos Santos Moreira","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I17974374","display_name":"Universidade de S\u00e3o Paulo","ror":"https://ror.org/036rp1748","country_code":"BR","type":"education","lineage":["https://openalex.org/I17974374"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Camila dos Santos Moreira","raw_affiliation_strings":["University of S\u00e3o Paulo,  Brazil","Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of S\u00e3o Paulo,  Brazil","institution_ids":["https://openalex.org/I17974374"]},{"raw_affiliation_string":"Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil","institution_ids":["https://openalex.org/I17974374"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5046977658","display_name":"Alessandro Morais Saviano","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I17974374","display_name":"Universidade de S\u00e3o Paulo","ror":"https://ror.org/036rp1748","country_code":"BR","type":"education","lineage":["https://openalex.org/I17974374"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Alessandro Morais Saviano","raw_affiliation_strings":["University of S\u00e3o Paulo,  Brazil","Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of S\u00e3o Paulo,  Brazil","institution_ids":["https://openalex.org/I17974374"]},{"raw_affiliation_string":"Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil","institution_ids":["https://openalex.org/I17974374"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5069291017","display_name":"Felipe Rebello Louren\u00e7o","orcid":"https://orcid.org/0000-0002-2630-151X","observed_orcids":["https://orcid.org/0000-0002-2630-151X"]},"institutions":[{"id":"https://openalex.org/I17974374","display_name":"Universidade de S\u00e3o Paulo","ror":"https://ror.org/036rp1748","country_code":"BR","type":"education","lineage":["https://openalex.org/I17974374"]}],"countries":["BR"],"is_corresponding":false,"raw_author_name":"Felipe Rebello Louren\u00e7o","raw_affiliation_strings":["University of S\u00e3o Paulo,  Brazil","Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of S\u00e3o Paulo,  Brazil","institution_ids":["https://openalex.org/I17974374"]},{"raw_affiliation_string":"Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo, Brazil","institution_ids":["https://openalex.org/I17974374"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I17974374"],"apc_list":null,"apc_paid":null,"fwci":16.2901,"has_fulltext":true,"cited_by_count":429,"citation_normalized_percentile":{"value":0.99434175,"is_in_top_1_percent":true,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":100},"biblio":{"volume":"54","issue":"spe","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11798","display_name":"Optimal Experimental Design Methods","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11798","display_name":"Optimal Experimental Design Methods","score":0.9984999895095825,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11460","display_name":"Analytical Methods in Pharmaceuticals","score":0.0010000000474974513,"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/T12547","display_name":"Pharmaceutical studies and practices","score":9.999999747378752e-05,"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/experimental-design","display_name":"experimental design","score":0.9620000123977661},{"id":"https://openalex.org/keywords/quality-by-design","display_name":"quality by design","score":0.9739999771118164},{"id":"https://openalex.org/keywords/drug-development","display_name":"drug development","score":0.7699999809265137},{"id":"https://openalex.org/keywords/analytical-method-development","display_name":"analytical method development","score":0.9789999723434448},{"id":"https://openalex.org/keywords/screening-designs","display_name":"screening designs","score":0.7239999771118164},{"id":"https://openalex.org/keywords/factorial-design","display_name":"factorial design","score":0.6439999938011169},{"id":"https://openalex.org/keywords/plackett-burman-design","display_name":"Plackett-Burman design","score":0.9470000267028809},{"id":"https://openalex.org/keywords/central-composite-design","display_name":"central composite design","score":0.9120000004768372},{"id":"https://openalex.org/keywords/box-behnken-design","display_name":"Box-Behnken design","score":1.0},{"id":"https://openalex.org/keywords/multiple-regression-model","display_name":"multiple regression model","score":0.6729999780654907},{"id":"https://openalex.org/keywords/lack-of-fit","display_name":"lack of fit","score":0.6439999938011169},{"id":"https://openalex.org/keywords/analysis-of-variance","display_name":"analysis of variance","score":0.6510000228881836},{"id":"https://openalex.org/keywords/residual-analysis","display_name":"residual analysis","score":0.550000011920929},{"id":"https://openalex.org/keywords/response-surface-optimization","display_name":"response surface optimization","score":0.5189999938011169}],"concepts":[{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.8902465105056763},{"id":"https://openalex.org/C34559072","wikidata":"https://www.wikidata.org/wiki/Q2334061","display_name":"Design of experiments","level":2,"score":0.844747006893158},{"id":"https://openalex.org/C169222746","wikidata":"https://www.wikidata.org/wiki/Q4116558","display_name":"Factorial experiment","level":2,"score":0.8365918397903442},{"id":"https://openalex.org/C16469947","wikidata":"https://www.wikidata.org/wiki/Q2400745","display_name":"Fractional factorial design","level":3,"score":0.6547641158103943},{"id":"https://openalex.org/C170295934","wikidata":"https://www.wikidata.org/wiki/Q4952019","display_name":"Box\u2013Behnken design","level":3,"score":0.5526837706565857},{"id":"https://openalex.org/C111374699","wikidata":"https://www.wikidata.org/wiki/Q7200396","display_name":"Plackett\u2013Burman design","level":3,"score":0.5443659424781799},{"id":"https://openalex.org/C2780449318","wikidata":"https://www.wikidata.org/wiki/Q18344773","display_name":"Critical quality attributes","level":3,"score":0.5205258131027222},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.47425734996795654},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.46852463483810425},{"id":"https://openalex.org/C92397422","wikidata":"https://www.wikidata.org/wiki/Q5062082","display_name":"Central composite design","level":3,"score":0.46706992387771606},{"id":"https://openalex.org/C28662235","wikidata":"https://www.wikidata.org/wiki/Q6736213","display_name":"Main effect","level":2,"score":0.4512714743614197},{"id":"https://openalex.org/C152877465","wikidata":"https://www.wikidata.org/wiki/Q208042","display_name":"Regression analysis","level":2,"score":0.4468296468257904},{"id":"https://openalex.org/C196083921","wikidata":"https://www.wikidata.org/wiki/Q7915758","display_name":"Variance (accounting)","level":2,"score":0.428634375333786},{"id":"https://openalex.org/C48921125","wikidata":"https://www.wikidata.org/wiki/Q10861030","display_name":"Linear regression","level":2,"score":0.4151473045349121},{"id":"https://openalex.org/C183696295","wikidata":"https://www.wikidata.org/wiki/Q2487696","display_name":"Biochemical engineering","level":1,"score":0.35045742988586426},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.3365388512611389},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.33423346281051636},{"id":"https://openalex.org/C150077022","wikidata":"https://www.wikidata.org/wiki/Q3136137","display_name":"Response surface methodology","level":2,"score":0.3136428892612457},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.3104565143585205},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.22727751731872559},{"id":"https://openalex.org/C21547014","wikidata":"https://www.wikidata.org/wiki/Q1423657","display_name":"Operations management","level":1,"score":0.06229785084724426},{"id":"https://openalex.org/C2776207758","wikidata":"https://www.wikidata.org/wiki/Q5303302","display_name":"Downstream (manufacturing)","level":2,"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/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.0},{"id":"https://openalex.org/C121955636","wikidata":"https://www.wikidata.org/wiki/Q4116214","display_name":"Accounting","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}],"mesh":[],"locations_count":6,"locations":[{"id":"doi:10.1590/s2175-97902018000001006","doi":"https://doi.org/10.1590/s2175-97902018000001006","is_oa":true,"landing_page_url":"https://doi.org/10.1590/s2175-97902018000001006","pdf_url":"http://www.scielo.br/pdf/bjps/v54nspe/2175-9790-bjps-54-spe-e01006.pdf","source":{"id":"https://openalex.org/S120884445","display_name":"Brazilian Journal of Pharmaceutical Sciences","issn_l":"1984-8250","issn":["1984-8250","2175-9790"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","poland-40","russia-white-list-3","scielo"],"host_organization":"https://openalex.org/P4310312331","host_organization_name":"University of S\u00e3o Paulo","host_organization_lineage":["https://openalex.org/P4310312331"],"host_organization_lineage_names":["University of S\u00e3o Paulo"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Brazilian Journal of Pharmaceutical Sciences","raw_type":"journal-article"},{"id":"pmh:002911702","doi":null,"is_oa":true,"landing_page_url":"http://www.scielo.br/pdf/bjps/v54nspe/2175-9790-bjps-54-spe-e01006.pdf","pdf_url":"http://www.scielo.br/pdf/bjps/v54nspe/2175-9790-bjps-54-spe-e01006.pdf","source":{"id":"https://openalex.org/S4306402641","display_name":"LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Cient\u00edficas)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4383465926","host_organization_name":"LA Referencia","host_organization_lineage":["https://openalex.org/I4383465926"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"instacron:USP","raw_type":"info:eu-repo/semantics/publishedVersion"},{"id":"pmh:oai:americanae.aecid.es:2362192","doi":null,"is_oa":true,"landing_page_url":"http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000700405","pdf_url":null,"source":{"id":"https://openalex.org/S4306400786","display_name":"Americanae (AECID Library)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Brazilian Journal of Pharmaceutical Sciences v.54 n.spe 2018","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:scielo:S1984-82502018000700405","doi":null,"is_oa":true,"landing_page_url":"http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000700405","pdf_url":null,"source":{"id":"https://openalex.org/S4306402641","display_name":"LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Cient\u00edficas)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4383465926","host_organization_name":"LA Referencia","host_organization_lineage":["https://openalex.org/I4383465926"],"host_organization_lineage_names":[],"type":"repository"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Brazilian Journal of Pharmaceutical Sciences v.54 n.spe 2018","raw_type":"info:eu-repo/semantics/article"},{"id":"pmh:oai:doaj.org/article:4c26a1bf4d68479894a11a95034751e2","doi":null,"is_oa":true,"landing_page_url":"https://doaj.org/article/4c26a1bf4d68479894a11a95034751e2","pdf_url":null,"source":{"id":"https://openalex.org/S4306401280","display_name":"DOAJ (DOAJ: Directory of Open Access Journals)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by-sa","license_id":"https://openalex.org/licenses/cc-by-sa","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Brazilian Journal of Pharmaceutical Sciences, Vol 54, Iss spe (2018)","raw_type":"article"},{"id":"pmh:oai:revistas.usp.br:article/153905","doi":null,"is_oa":true,"landing_page_url":"https://www.revistas.usp.br/bjps/article/view/153905","pdf_url":null,"source":{"id":"https://openalex.org/S4306402641","display_name":"LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Cient\u00edficas)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4383465926","host_organization_name":"LA Referencia","host_organization_lineage":["https://openalex.org/I4383465926"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"instacron:USP","raw_type":"info:eu-repo/semantics/article"}],"best_oa_location":{"id":"doi:10.1590/s2175-97902018000001006","doi":"https://doi.org/10.1590/s2175-97902018000001006","is_oa":true,"landing_page_url":"https://doi.org/10.1590/s2175-97902018000001006","pdf_url":"http://www.scielo.br/pdf/bjps/v54nspe/2175-9790-bjps-54-spe-e01006.pdf","source":{"id":"https://openalex.org/S120884445","display_name":"Brazilian Journal of Pharmaceutical Sciences","issn_l":"1984-8250","issn":["1984-8250","2175-9790"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","dongbi-b","poland-40","russia-white-list-3","scielo"],"host_organization":"https://openalex.org/P4310312331","host_organization_name":"University of S\u00e3o Paulo","host_organization_lineage":["https://openalex.org/P4310312331"],"host_organization_lineage_names":["University of S\u00e3o Paulo"],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Brazilian Journal of Pharmaceutical Sciences","raw_type":"journal-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320320997","display_name":"Funda\u00e7\u00e3o de Amparo \u00e0 Pesquisa do Estado de S\u00e3o Paulo","ror":"https://ror.org/02ddkpn78"},{"id":"https://openalex.org/F4320322025","display_name":"Conselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico","ror":"https://ror.org/03swz6y49"}],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2901020484.pdf","grobid_xml":"https://content.openalex.org/works/W2901020484.grobid-xml"},"referenced_works_count":35,"referenced_works":["https://openalex.org/W846550035","https://openalex.org/W1820815707","https://openalex.org/W1911527543","https://openalex.org/W1911798041","https://openalex.org/W1990393375","https://openalex.org/W1991529707","https://openalex.org/W1997527242","https://openalex.org/W1999481657","https://openalex.org/W2017711000","https://openalex.org/W2029584965","https://openalex.org/W2032439697","https://openalex.org/W2036819183","https://openalex.org/W2042790737","https://openalex.org/W2047182126","https://openalex.org/W2048058024","https://openalex.org/W2060332933","https://openalex.org/W2073750282","https://openalex.org/W2088376206","https://openalex.org/W2088482441","https://openalex.org/W2208072425","https://openalex.org/W2324791959","https://openalex.org/W2340205569","https://openalex.org/W2469189045","https://openalex.org/W2505448267","https://openalex.org/W2519358881","https://openalex.org/W2550943378","https://openalex.org/W2560468344","https://openalex.org/W2564526769","https://openalex.org/W2578654374","https://openalex.org/W2586783706","https://openalex.org/W2591897832","https://openalex.org/W2592350771","https://openalex.org/W2616929824","https://openalex.org/W2741336675","https://openalex.org/W2765633607"],"related_works":["https://openalex.org/W2997263170","https://openalex.org/W3094007350","https://openalex.org/W4285275742","https://openalex.org/W3012315496","https://openalex.org/W7164575246","https://openalex.org/W3216928389","https://openalex.org/W2586783706","https://openalex.org/W4386785963","https://openalex.org/W4390350722","https://openalex.org/W3124125368"],"abstract_inverted_index":{"According":[0],"to":[1,39,126],"Quality":[2,78],"by":[3,79],"Design":[4,31,70,80],"(QbD)":[5],"concept,":[6],"quality":[7,25],"should":[8],"be":[9],"built":[10],"into":[11],"product/method":[12],"during":[13],"pharmaceutical/analytical":[14],"development.":[15],"Usually,":[16],"there":[17],"are":[18],"many":[19],"input":[20,48],"factors":[21,49],"that":[22],"may":[23],"affect":[24],"of":[26,32,43,47,54,69,71,89,136,151,166],"product":[27],"and":[28,45,57,64,87,102,105,117,147,149,168],"methods.":[29,59],"Recently,":[30],"Experiments":[33,72],"(DoE)":[34,73],"have":[35],"been":[36],"widely":[37],"used":[38],"understand":[40],"the":[41,51,85,90,122,134,163],"effects":[42],"multidimensional":[44],"interactions":[46],"on":[50],"output":[52],"responses":[53],"pharmaceutical":[55,75,167],"products":[56],"analytical":[58,77,169],"This":[60,82],"paper":[61],"provides":[62],"theoretical":[63],"practical":[65],"considerations":[66],"for":[67],"implementation":[68],"in":[74,158],"and/or":[76],"(QbD).":[81],"review":[83],"illustrates":[84],"principles":[86],"applications":[88],"most":[91],"common":[92],"screening":[93],"designs,":[94,107],"such":[95,108],"as":[96,109],"two-level":[97],"full":[98,111],"factorial,":[99,101,112],"fractionate":[100],"Plackett-Burman":[103],"designs;":[104],"optimization":[106],"three-level":[110],"central":[113],"composite":[114],"designs":[115],"(CCD),":[116],"Box-Behnken":[118],"designs.":[119],"In":[120],"addition,":[121],"main":[123,164],"aspects":[124],"related":[125],"multiple":[127],"regression":[128,139,152],"model":[129],"adjustment":[130],"were":[131],"discussed,":[132],"including":[133],"analysis":[135],"variance":[137],"(ANOVA),":[138],"significance,":[140],"residuals":[141],"analysis,":[142],"determination":[143],"coefficients":[144],"(R2,":[145],"R2-adj,":[146],"R2-pred),":[148],"lack-of-fit":[150],"model.":[153],"Therefore,":[154],"DoE":[155],"was":[156],"presented":[157],"detail":[159],"since":[160],"it":[161],"is":[162],"component":[165],"QbD.":[170]},"counts_by_year":[{"year":2026,"cited_by_count":70},{"year":2025,"cited_by_count":71},{"year":2024,"cited_by_count":70},{"year":2023,"cited_by_count":66},{"year":2022,"cited_by_count":69},{"year":2021,"cited_by_count":45},{"year":2020,"cited_by_count":31},{"year":2019,"cited_by_count":6},{"year":2018,"cited_by_count":1}],"updated_date":"2026-11-06T12:05:46.655746","created_date":"2018-11-29T00:00:00"}