{"created":"2023-06-19T09:07:04.073207+00:00","id":462,"links":{},"metadata":{"_buckets":{"deposit":"23c0964b-6648-47c0-9248-f996fcdb2a81"},"_deposit":{"created_by":15,"id":"462","owners":[15],"pid":{"revision_id":0,"type":"depid","value":"462"},"status":"published"},"_oai":{"id":"oai:stella.repo.nii.ac.jp:00000462","sets":[]},"author_link":["506","380","114","737","738","739","394"],"item_10001_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2013","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageEnd":"49","bibliographicPageStart":"39","bibliographicVolumeNumber":"61","bibliographic_titles":[{"bibliographic_title":"Chemical and Pharmaceutical Bulletin"}]}]},"item_10001_description_19":{"attribute_name":"フォーマット","attribute_value_mlt":[{"subitem_description":"application/pdf","subitem_description_type":"Other"}]},"item_10001_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"A novel approach to establishing the design space for the oral formulation manufacturing process was investigated. A response surface method incorporating multivariate spline interpolation was applied to overcome the nonlinear problem, which is always problematic in pharmaceutical development studies, and a bootstrap resampling technique, polynomial approximation technique, and 95% confidence intervals based on a nonparametric approach were applied to estimate the reliability of the established design space derived from the nonlinear response surface model. The critical quality attributes (CQAs) of intermediate material rather than the critical process parameters (CPPs) were chosen as the causal factors for the response variables, which were CQAs of the final product to avoid scale-gap and equipment-gap. This enabled the effective use of data sets accumulated during all pharmaceutical development studies. It was confirmed that a conservative border as well as an optimistic border of the design space for practical use was obtained considering the variability of the border of the design spaces on nonlinear response surfaces. Furthermore, the nonlinear response surface model using CQAs of intermediate material derived from data sets of a laboratory scale study and pilot scale studies could predict the CQA of the final product (2.5 h dissolution of commercial-scale study) with high accuracy. Consequently, the proposed novel approach overcame all of the difficulties for the manufacturing process development of oral formulations and this is the first study to demonstrate the effectiveness of the design space using CQA of intermediate material for the oral formulation manufacturing process.","subitem_description_type":"Abstract"}]},"item_10001_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"日本薬学会"}]},"item_10001_relation_12":{"attribute_name":"論文ID（NAID）","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"130003360719","subitem_relation_type_select":"NAID"}}]},"item_10001_relation_14":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"info:10.1248/cpb.c12-00743","subitem_relation_type_select":"DOI"}}]},"item_10001_rights_15":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"日本薬学会"}]},"item_10001_source_id_11":{"attribute_name":"書誌レコードID","attribute_value_mlt":[{"subitem_source_identifier":"AA00602100","subitem_source_identifier_type":"NCID"}]},"item_10001_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0009-2363","subitem_source_identifier_type":"ISSN"}]},"item_10001_version_type_20":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Norioka, Tadashi","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"394","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Hayashi, Yoshihiro","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"506","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Onuki, Yoshinori","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"380","nameIdentifierScheme":"WEKO"},{"nameIdentifier":"1000010350224","nameIdentifierScheme":"NRID","nameIdentifierURI":" "},{"nameIdentifier":"10350224","nameIdentifierScheme":"e-Rad","nameIdentifierURI":"https://kaken.nii.ac.jp/ja/search/?qm=10350224"}]},{"creatorNames":[{"creatorName":"Andou, Hirotaka","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"737","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Tsunashima, Daisuke","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"738","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Yamashita, Kazunari","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"739","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Takayama, Kozo","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"114","nameIdentifierScheme":"WEKO"},{"nameIdentifier":"1000000130758","nameIdentifierScheme":"CiNii ID","nameIdentifierURI":"http://ci.nii.ac.jp/nrid/1000000130758"},{"nameIdentifier":"1000000130758","nameIdentifierScheme":"NRID","nameIdentifierURI":" "},{"nameIdentifier":"130758","nameIdentifierScheme":"e-Rad","nameIdentifierURI":"https://kaken.nii.ac.jp/ja/search/?qm=130758"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2016-02-03"}],"displaytype":"detail","filename":"ChemPharmBull_61‐1_p39.pdf","filesize":[{"value":"2.0 MB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"ChemPharmBull_61‐1_p39.pdf ","url":"https://stella.repo.nii.ac.jp/record/462/files/ChemPharmBull_61‐1_p39.pdf"},"version_id":"d10826fd-fccf-4bdb-a94f-6cb4d7dc78d3"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"design space","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"experimental design","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"response surface method","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"multivariate statistical analysis","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"confidence interval","subitem_subject_language":"en","subitem_subject_scheme":"Other"},{"subitem_subject":"critical quality attribute","subitem_subject_language":"en","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"A Novel Approach to Establishing the Design Space for the Oral Formulation Manufacturing Process","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"A Novel Approach to Establishing the Design Space for the Oral Formulation Manufacturing Process","subitem_title_language":"en"}]},"item_type_id":"10001","owner":"15","path":["127"],"pubdate":{"attribute_name":"公開日","attribute_value":"2016-02-03"},"publish_date":"2016-02-03","publish_status":"0","recid":"462","relation_version_is_last":true,"title":["A Novel Approach to Establishing the Design Space for the Oral Formulation Manufacturing Process"],"weko_creator_id":"15","weko_shared_id":-1},"updated":"2023-06-19T09:20:56.641688+00:00"}