Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing
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- Ishimoto Hayato
- Formulation Research, Pharmaceutical Science & Technology Core Function Unit, Medicine Development Center, Eisai Co., Ltd.
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- Kano Manabu
- Department of Systems Science, Kyoto University
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- Sugiyama Hirokazu
- Department of Chemical System Engineering, The University of Tokyo
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- Takeuchi Hirofumi
- Advanced Pharmaceutical Process Engineering, Gifu Pharmaceutical University
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- Terada Katsuhide
- Faculty of Pharmacy, Takasaki University of Health and Welfare
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- Aoyama Atsushi
- Office of New Drug III, Pharmaceuticals and Medical Devices Agency
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- Shoda Takuji
- Division of Organic Chemistry, National Institute of Health Sciences
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- Demizu Yosuke
- Division of Organic Chemistry, National Institute of Health Sciences
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- Shimamura Jinen
- Pharmaceutical Research Dept. Research & Development Headquarters, TAKATA Pharmaceutical Co., Ltd.
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- Yokoyama Reiji
- CMC R&D Division, Shionogi Co., Ltd., Formulation R&D Laboratory
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- Miyamoto Yuji
- Formulation Research & Pharmaceutical Process Group, CMC R&D Center, Kyowa Kirin Co., Ltd.
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- Hasegawa Koji
- Technical Division, POWREX Corporation
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- Serizawa Masaru
- BeatSensing Co., Ltd.
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- Unosawa Kazuomi
- R&D Laboratotory, FREUND CORPORATION
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- Osaki Kazuo
- Spectroscopy, Metrohm Japan Ltd.
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- Asai Naochika
- Industrial Machinery Division, DALTON CORPORATION
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- Matsuda Yoshihiro
- Pharmaceuticals and Medical Devices Agency
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Abstract
<p>As a result of the research activities of the Japan Agency for Medical Research and Development (AMED), this document aims to show an approach to establishing control strategy for continuous manufacturing of oral solid dosage forms. The methods of drug development, technology transfer, process control, and quality control used in the current commercial batch manufacturing would be effective also in continuous manufacturing, while there are differences in the process development using continuous manufacturing and batch manufacturing. This document introduces an example of the way of thinking for establishing a control strategy for continuous manufacturing processes.</p>
Journal
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- Chemical and Pharmaceutical Bulletin
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Chemical and Pharmaceutical Bulletin 69 (2), 211-217, 2021-02-01
The Pharmaceutical Society of Japan
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Keywords
Details 詳細情報について
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- CRID
- 1391694356264233984
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- NII Article ID
- 130007979432
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- NII Book ID
- AA00602100
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- ISSN
- 13475223
- 00092363
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- NDL BIB ID
- 031242277
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- PubMed
- 33298636
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- Text Lang
- en
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- Data Source
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
- KAKEN
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- Abstract License Flag
- Disallowed