{"doi":"10.1016/j.ejpb.2012.03.003","title":"A quality by design study applied to an industrial pharmaceutical fluid bed granulation","abstract":null,"journal":"European Journal of Pharmaceutics and Biopharmaceutics","year":2012,"id":599112,"datarank":0.692268077526189,"base_score":4.61512051684126,"endowment":4.61512051684126,"self_citation_contribution":0.692268077526189,"citation_network_contribution":0.0,"self_endowment_contribution":0.692268077526189,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":100,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1535481,"name":"Dirk Lochmann","orcid":null,"position":1,"is_corresponding":false},{"id":1535482,"name":"Gabriele Reich","orcid":null,"position":2,"is_corresponding":false},{"id":1535483,"name":"José C. Menezes","orcid":null,"position":3,"is_corresponding":false},{"id":1535484,"name":"Thorsten Herdling","orcid":null,"position":4,"is_corresponding":false},{"id":1535485,"name":"Jens Schewitz","orcid":null,"position":5,"is_corresponding":false},{"id":1535480,"name":"Vera Lourenço","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"A quality by design study applied to an industrial pharmaceutical fluid bed granulation","abstract":"The pharmaceutical industry is encouraged within Quality by Design (QbD) to apply science-based manufacturing principles to assure quality not only of new but also of existing processes. This paper presents how QbD principles can be applied to an existing industrial pharmaceutical fluid bed granulation (FBG) process. A three-step approach is presented as follows: (1) implementation of Process Analytical Technology (PAT) monitoring tools at the industrial scale process, combined with multivariate data analysis (MVDA) of process and PAT data to increase the process knowledge; (2) execution of scaled-down designed experiments at a pilot scale, with adequate PAT monitoring tools, to investigate the process response to intended changes in Critical Process Parameters (CPPs); and finally (3) the definition of a process Design Space (DS) linking CPPs to Critical to Quality Attributes (CQAs), within which product quality is ensured by design, and after scale-up enabling its use at the industrial process scale. The proposed approach was developed for an existing industrial process. Through enhanced process knowledge established a significant reduction in product CQAs, variability already within quality specifications ranges was achieved by a better choice of CPPs values. The results of such step-wise development and implementation are described.","is_dataset_classified":null,"base_score":4.61512051684126,"endowment":4.61512051684126,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"22446063","pmcid":null,"openalex_id":"https://openalex.org/W2073750282","authors":[],"funders":[],"total_grants":0,"fwci":7.1108,"citation_percentile":0.97654606,"influential_citations":0,"citation_trend":[{"year":2012,"count":1},{"year":2013,"count":13},{"year":2014,"count":7},{"year":2015,"count":3},{"year":2016,"count":8},{"year":2017,"count":10},{"year":2018,"count":11},{"year":2019,"count":5},{"year":2020,"count":8},{"year":2021,"count":8},{"year":2022,"count":5},{"year":2023,"count":10},{"year":2024,"count":5},{"year":2025,"count":3},{"year":2026,"count":3}],"oa_status":"closed","license":"https://www.elsevier.com/tdm/userlicense/1.0/","oa_locations":[{"url":"https://api.elsevier.com/content/article/PII:S0939641112000781?httpAccept=text/xml","host_type":"publisher"},{"url":"https://api.elsevier.com/content/article/PII:S0939641112000781?httpAccept=text/plain","host_type":"publisher"},{"url":"https://doi.org/10.1016/j.ejpb.2012.03.003","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/22446063","host_type":"repository"}],"fields_of_study":["Advanced Statistical Process Monitoring","Fault Detection and Control Systems","Mineral Processing and Grinding","Drug Compounding","Drug Industry","Multivariate Analysis","Pharmaceutical Preparations","Quality Control","Research Design","Risk Assessment","Technology, Pharmaceutical"],"mesh_terms":["Drug Compounding","Drug Industry","Pharmaceutical Preparations","Quality Control","Research Design","Technology, Pharmaceutical","Multivariate Analysis","Risk Assessment"],"keywords":["Quality by Design","Critical quality attributes","Process analytical technology","Process validation","Process (computing)","Pharmaceutical manufacturing","Granulation","Process engineering","Quality (philosophy)","Computer science","Process design","Scale (ratio)","SCALE-UP","Manufacturing engineering","Process control","Process capability","Work in process","Engineering","Verification and validation","Operations management","Process integration"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Industry, innovation and infrastructure"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-07-28T18:42:50.928469Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}