Quality by Design (QbD) application for the pharmaceutical development process
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Lee, Sang-Ho | - |
dc.contributor.author | Kim, Jin-Ki | - |
dc.contributor.author | Jee, Jun-Pil | - |
dc.contributor.author | Jang, Dong-Jin | - |
dc.contributor.author | Park, Young-Joon | - |
dc.contributor.author | Kim, Joo-Eun | - |
dc.date.accessioned | 2023-02-21T05:35:53Z | - |
dc.date.available | 2023-02-21T05:35:53Z | - |
dc.date.issued | 2022-11 | - |
dc.identifier.issn | 2093-5552 | - |
dc.identifier.issn | 2093-6214 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/erica/handle/2021.sw.erica/111473 | - |
dc.description.abstract | Background Quality by Design (QbD) is a pharmaceutical quality management system that predicts, controls, and systematically responds to risks that may occur in the research stage and manufacturing process. There are many articles on how to improve quality through application of the QbD system, but the methodology surrounding how to specifically apply this process is limited. The purpose of this review was to provide accurate information on drug development process and overcome the difficulties of developing QbD-applied drug products through an appropriate application method. Area covered QbD-based pharmaceuticals are continuously being developed worldwide, helping to identify potential risks, and managing all aspects, from drug design to patient consumption, further enabling the patient to be administered a high-quality drugs based on their design. In this study, a basic knowledge of QbD, its application and effectiveness during drug development will be discussed. Expert opinion Our results suggest that a QbD for drug development can reduce risk to patients, improve drug quality, and continuously produce superior quality drug products. | - |
dc.format.extent | 34 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | 한국약제학회 | - |
dc.title | Quality by Design (QbD) application for the pharmaceutical development process | - |
dc.title.alternative | Quality by Design (QbD) application for the pharmaceutical development process | - |
dc.type | Article | - |
dc.publisher.location | 대한민국 | - |
dc.identifier.doi | 10.1007/s40005-022-00575-x | - |
dc.identifier.scopusid | 2-s2.0-85140951895 | - |
dc.identifier.wosid | 000847261000001 | - |
dc.identifier.bibliographicCitation | Journal of Pharmaceutical Investigation, v.52, no.6, pp 649 - 682 | - |
dc.citation.title | Journal of Pharmaceutical Investigation | - |
dc.citation.volume | 52 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 649 | - |
dc.citation.endPage | 682 | - |
dc.type.docType | Review | - |
dc.identifier.kciid | ART002896803 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | LIFE-CYCLE MANAGEMENT | - |
dc.subject.keywordPlus | RISK-ASSESSMENT | - |
dc.subject.keywordPlus | FORMULATION DEVELOPMENT | - |
dc.subject.keywordPlus | BY-DESIGN | - |
dc.subject.keywordPlus | DRUG-DELIVERY | - |
dc.subject.keywordPlus | TABLET FORMULATION | - |
dc.subject.keywordPlus | TOPICAL DELIVERY | - |
dc.subject.keywordPlus | IN-VITRO | - |
dc.subject.keywordPlus | OPTIMIZATION | - |
dc.subject.keywordPlus | PRODUCT | - |
dc.subject.keywordAuthor | Quality by Design | - |
dc.subject.keywordAuthor | Pharmaceutical development process | - |
dc.subject.keywordAuthor | QTPP | - |
dc.subject.keywordAuthor | CQAs | - |
dc.subject.keywordAuthor | CMAs | - |
dc.subject.keywordAuthor | CPPs | - |
dc.identifier.url | https://link.springer.com/article/10.1007/s40005-022-00575-x | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
55 Hanyangdeahak-ro, Sangnok-gu, Ansan, Gyeonggi-do, 15588, Korea+82-31-400-4269 sweetbrain@hanyang.ac.kr
COPYRIGHT © 2021 HANYANG UNIVERSITY. ALL RIGHTS RESERVED.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.