{"id":"https://openalex.org/W2764034504","doi":"https://doi.org/10.3329/bjsir.v52i3.34160","title":"Application of Laney control chart in assessment of microbiological quality of oral pharmaceutical filterable products","display_name":"Application of Laney control chart in assessment of microbiological quality of oral pharmaceutical filterable products","publication_year":2017,"publication_date":"2017-10-03","ids":{"openalex":"https://openalex.org/W2764034504","doi":"https://doi.org/10.3329/bjsir.v52i3.34160","mag":"2764034504"},"language":"en","primary_location":{"id":"doi:10.3329/bjsir.v52i3.34160","doi":"https://doi.org/10.3329/bjsir.v52i3.34160","is_oa":true,"landing_page_url":"https://doi.org/10.3329/bjsir.v52i3.34160","pdf_url":"https://www.banglajol.info/index.php/BJSIR/article/download/34160/23030","source":{"id":"https://openalex.org/S58516463","display_name":"Bangladesh Journal of Scientific and Industrial Research","issn_l":"0304-9809","issn":["0304-9809","2224-7157"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","jpps-2"],"host_organization":"https://openalex.org/P4310319539","host_organization_name":"Bangladesh Council of Scientific and Industrial Research","host_organization_lineage":["https://openalex.org/P4310319539"],"host_organization_lineage_names":["Bangladesh Council of Scientific and Industrial Research"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Bangladesh Journal of Scientific and Industrial Research","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":"https://www.banglajol.info/index.php/BJSIR/article/download/34160/23030","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5057718323","display_name":"Mostafa Essam Eissa","orcid":"https://orcid.org/0000-0003-3562-5935","observed_orcids":["https://orcid.org/0000-0003-3562-5935"]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"ME Eissa","raw_affiliation_strings":["HIKMA Pharma, 2nd Industrial Zone, Giza"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"HIKMA Pharma, 2nd Industrial Zone, Giza","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5057718323"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.1632,"has_fulltext":true,"cited_by_count":11,"citation_normalized_percentile":{"value":0.54969045,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"52","issue":"3","first_page":"239","last_page":"246"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11443","display_name":"Advanced Statistical Process Monitoring","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"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/T11443","display_name":"Advanced Statistical Process Monitoring","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"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":0.00019999999494757503,"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/T12878","display_name":"Pharmaceutical Quality and Counterfeiting","score":9.999999747378752e-05,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/microbiological-quality","display_name":"microbiological quality","score":0.7509999871253967},{"id":"https://openalex.org/keywords/total-viable-count","display_name":"total viable count","score":0.9430000185966492},{"id":"https://openalex.org/keywords/overdispersion","display_name":"overdispersion","score":0.6650000214576721},{"id":"https://openalex.org/keywords/underdispersion","display_name":"underdispersion","score":0.9300000071525574},{"id":"https://openalex.org/keywords/out-of-control-points","display_name":"out-of-control points","score":0.6830000281333923},{"id":"https://openalex.org/keywords/good-manufacturing-practices","display_name":"good manufacturing practices","score":0.6430000066757202},{"id":"https://openalex.org/keywords/pharmaceutical-quality-control","display_name":"pharmaceutical quality control","score":0.6069999933242798}],"concepts":[{"id":"https://openalex.org/C34008175","wikidata":"https://www.wikidata.org/wiki/Q975018","display_name":"Bioburden","level":2,"score":0.7650925517082214},{"id":"https://openalex.org/C196985124","wikidata":"https://www.wikidata.org/wiki/Q1369242","display_name":"Control chart","level":3,"score":0.7532768249511719},{"id":"https://openalex.org/C190812933","wikidata":"https://www.wikidata.org/wiki/Q28923","display_name":"Chart","level":2,"score":0.6590205430984497},{"id":"https://openalex.org/C2779709869","wikidata":"https://www.wikidata.org/wiki/Q1292017","display_name":"Good manufacturing practice","level":3,"score":0.5726866126060486},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.44882848858833313},{"id":"https://openalex.org/C110121322","wikidata":"https://www.wikidata.org/wiki/Q865811","display_name":"Distribution (mathematics)","level":2,"score":0.43268248438835144},{"id":"https://openalex.org/C113644684","wikidata":"https://www.wikidata.org/wiki/Q1356717","display_name":"Statistical process control","level":3,"score":0.4108273983001709},{"id":"https://openalex.org/C200601418","wikidata":"https://www.wikidata.org/wiki/Q2193887","display_name":"Reliability engineering","level":1,"score":0.39750850200653076},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.3658672571182251},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.35038405656814575},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.3160519301891327},{"id":"https://openalex.org/C21547014","wikidata":"https://www.wikidata.org/wiki/Q1423657","display_name":"Operations management","level":1,"score":0.3061782717704773},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.2825637459754944},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.20400407910346985},{"id":"https://openalex.org/C98045186","wikidata":"https://www.wikidata.org/wiki/Q205663","display_name":"Process (computing)","level":2,"score":0.1365443766117096},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.08744743466377258},{"id":"https://openalex.org/C134306372","wikidata":"https://www.wikidata.org/wiki/Q7754","display_name":"Mathematical analysis","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/C2780511413","wikidata":"https://www.wikidata.org/wiki/Q18749628","display_name":"Regulatory affairs","level":2,"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/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.3329/bjsir.v52i3.34160","doi":"https://doi.org/10.3329/bjsir.v52i3.34160","is_oa":true,"landing_page_url":"https://doi.org/10.3329/bjsir.v52i3.34160","pdf_url":"https://www.banglajol.info/index.php/BJSIR/article/download/34160/23030","source":{"id":"https://openalex.org/S58516463","display_name":"Bangladesh Journal of Scientific and Industrial Research","issn_l":"0304-9809","issn":["0304-9809","2224-7157"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","jpps-2"],"host_organization":"https://openalex.org/P4310319539","host_organization_name":"Bangladesh Council of Scientific and Industrial Research","host_organization_lineage":["https://openalex.org/P4310319539"],"host_organization_lineage_names":["Bangladesh Council of Scientific and Industrial Research"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Bangladesh Journal of Scientific and Industrial Research","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.3329/bjsir.v52i3.34160","doi":"https://doi.org/10.3329/bjsir.v52i3.34160","is_oa":true,"landing_page_url":"https://doi.org/10.3329/bjsir.v52i3.34160","pdf_url":"https://www.banglajol.info/index.php/BJSIR/article/download/34160/23030","source":{"id":"https://openalex.org/S58516463","display_name":"Bangladesh Journal of Scientific and Industrial Research","issn_l":"0304-9809","issn":["0304-9809","2224-7157"],"is_oa":true,"is_in_doaj":true,"is_core":false,"listed_in":["doaj","jpps-2"],"host_organization":"https://openalex.org/P4310319539","host_organization_name":"Bangladesh Council of Scientific and Industrial Research","host_organization_lineage":["https://openalex.org/P4310319539"],"host_organization_lineage_names":["Bangladesh Council of Scientific and Industrial Research"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Bangladesh Journal of Scientific and Industrial Research","raw_type":"journal-article"},"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":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W2764034504.pdf","grobid_xml":"https://content.openalex.org/works/W2764034504.grobid-xml"},"referenced_works_count":15,"referenced_works":["https://openalex.org/W1995814662","https://openalex.org/W2024858072","https://openalex.org/W2126155065","https://openalex.org/W2144884844","https://openalex.org/W2187117382","https://openalex.org/W2236358226","https://openalex.org/W2249241757","https://openalex.org/W2287230045","https://openalex.org/W2401000591","https://openalex.org/W2410198972","https://openalex.org/W2509465812","https://openalex.org/W2550872220","https://openalex.org/W2611828351","https://openalex.org/W2981151804","https://openalex.org/W4243328760"],"related_works":["https://openalex.org/W2742467084","https://openalex.org/W3199217992","https://openalex.org/W3199583510","https://openalex.org/W4414258565","https://openalex.org/W4385948367","https://openalex.org/W2533288850","https://openalex.org/W2899092735","https://openalex.org/W7100517144","https://openalex.org/W3029878712","https://openalex.org/W2784428732"],"abstract_inverted_index":{"Evaluation":[0],"of":[1,4,14,23,26,36,38,60,84,105,130,136,157,160,180],"microbiological":[2,64,178],"quality":[3],"pharmaceutical":[5,181],"product":[6],"is":[7,30],"an":[8],"important":[9],"criterion":[10],"for":[11,62,107,155],"safe":[12],"release":[13],"the":[15,19,24,34,39,82,92,113,161],"dosage":[16,182],"form":[17],"to":[18,32,42,90,111,151,176],"drug":[20],"market.":[21],"Monitoring":[22],"stability":[25,65,159],"monitored":[27,56],"characteristic":[28,179],"attribute":[29,166],"crucial":[31],"judge":[33],"degree":[35],"compliance":[37],"manufacturing":[40,47],"processes":[41],"reproducible":[43],"procedures":[44],"and":[45],"good":[46],"practice":[48],"(GMP).":[49],"Two":[50],"non-sterile":[51],"liquid":[52],"oral":[53],"products":[54,109,126],"were":[55],"during":[57],"ten":[58],"months":[59],"study":[61],"their":[63,137],"characteristics":[66],"using":[67,98],"control":[68,167],"charts.":[69],"Since":[70],"total":[71],"viable":[72],"count":[73],"(TVC)":[74],"results":[75,104,185],"did":[76],"not":[77],"follow":[78,112],"any":[79],"distribution":[80,115,117],"type,":[81],"application":[83],"Laney":[85,165],"U?":[86],"chart":[87,168],"was":[88],"found":[89],"be":[91,170],"best":[93],"approach":[94],"in":[95,116,149,192],"such":[96],"instances":[97],"relevant":[99],"statistical":[100],"software":[101],"packages.":[102],"The":[103],"TVC":[106],"both":[108,125],"failed":[110],"closest":[114],"fitting":[118],"test":[119],"at":[120],"?":[121],"=":[122],"0.05.":[123],"Interestingly,":[124],"demonstrated":[127],"several":[128],"spots":[129],"out-of-control":[131],"(OOC)":[132],"states,":[133],"although":[134],"none":[135],"batches":[138],"showed":[139],"out-of-specification":[140],"(OOS)":[141],"results.":[142],"These":[143],"OOC":[144],"conditions":[145],"require":[146],"further":[147],"investigations":[148],"order":[150],"provide":[152],"corrective/preventive":[153],"actions":[154],"improvement":[156],"bioburden":[158],"manufactured":[162],"pharmaceuticals.":[163],"Accordingly,":[164],"may":[169],"regarded":[171],"as":[172],"very":[173],"handy":[174],"tool":[175],"evaluate":[177],"form,":[183],"when":[184],"show":[186],"significant":[187],"over-dispersion":[188],"or":[189],"under-dispersion":[190],"pattern":[191],"data":[193],"distribution.Bangladesh":[194],"J.":[195],"Sci.":[196],"Ind.":[197],"Res.":[198],"52(3),":[199],"239-246,":[200],"2017":[201]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":2},{"year":2024,"cited_by_count":2},{"year":2023,"cited_by_count":1},{"year":2021,"cited_by_count":4},{"year":2019,"cited_by_count":1}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2017-10-20T00:00:00"}