Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

Kuno Kiyohito; Toyoshima Satoshi

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Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

机译：使用“按质量设计”方法回顾日本制药业的经验和监管挑战

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Background: A significant number of inquiries are issued during the review of pharmaceutical products developed using the quality-by-design (QbD) approach in Japan. The purpose of this article was to identify key elements specific to QbD development that should be described in the Quality Overall Summary (QOS) dossier.

机译：背景：在审查使用日本按设计质量（QbD）方法开发的药品时，进行了大量询问。本文的目的是确定特定于QbD开发的关键要素，这些要素应在质量总体摘要（QOS）档案中进行描述。

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《Therapeutic innovation & regulatory science.》 |2016年第3期|共7页
作者
Kuno Kiyohito; Toyoshima Satoshi;
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正文语种 eng
中图分类药学;
关键词
quality-by-design (QbD); control strategy; design space; real-time release (RTR); quality overall summary;

机译：设计质量（QbD）;控制策略;设计空间;实时发布（RTR）;质量总体摘要;

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1. Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach [J] . Kuno Kiyohito, Toyoshima Satoshi Therapeutic innovation & regulatory science. . 2016,第3期

机译：使用“按质量设计”方法回顾日本制药业的经验和监管挑战
2. Using an innovative Quality-by-Design approach for development of a stability indicating UHPLC method for ebastine in the API and pharmaceutical formulations [J] . SchmidtA.H., MolnárI. Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis . 2013,第Null期

机译：使用创新的按质量设计方法开发稳定性指示剂，用于针对API和药物制剂中的依巴斯汀的UHPLC方法
3. Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development. [J] . Wu H, White M, Khan MA International Journal of Pharmaceutics . 2011,第1a2期

机译：设计质量（QbD）：一种用于动态制药共沉淀过程表征和过程设计空间开发的集成过程分析技术（PAT）方法。
4. FRENCH APPROACH TO REGULATORY REVIEW: LESSONS LEARNED FROM THE EXPERIENCE OF THE LAST 20 YEARS [C] . D. CONTE, O. LAREYNIE, C. MESSIER International Conference on Lessons Learned From the Decommissioning of Nuclear Facilities and the Safe Termination of Nuclear Activities . 2007

机译：法国监管综述方法：从过去20年的经验中汲取的经验教训
5. AN ANALYSIS OF DRUG REGULATORY AFFAIRS AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT IN FRANCE, JAPAN AND THE UNITED STATES 1960-1980 (LAWS). [D] . REICH, JACK WAYNE. 1984

机译：1960-1980年法国，日本和美国的药物管制情况和药物研发分析。
6. The Specialist in Medicines Development (SMD) as a Vocational Program in Pharmaceutical Medicine: The Japanese and Italian Experience [O] . Domenico Criscuolo, Kyoko Imamura, Ingrid Klingmann 2020

机译：作为医药专业课程的药物开发专家（SMD）：日本和意大利的经验
7. The Specialist in Medicines Development (SMD) as a Vocational Program in Pharmaceutical Medicine: The Japanese and Italian Experience [O] . Domenico Criscuolo, Kyoko Imamura, Ingrid Klingmann 2020

机译：药品发展专家（SMD）作为制药中的职业计划：日本和意大利经验

Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

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