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1 0 0 0 OA Approach to Establishment of Control Strategy for Oral Solid Dosage Forms Using Continuous Manufacturing

著者
Hayato Ishimoto Manabu Kano Hirokazu Sugiyama Hirofumi Takeuchi Katsuhide Terada Atsushi Aoyama Takuji Shoda Yosuke Demizu Jinen Shimamura Reiji Yokoyama Yuji Miyamoto Koji Hasegawa Masaru Serizawa Kazuomi Unosawa Kazuo Osaki Naochika Asai Yoshihiro Matsuda
出版者
The Pharmaceutical Society of Japan
雑誌
Chemical and Pharmaceutical Bulletin (ISSN:00092363)
巻号頁・発行日
vol.69, no.2, pp.211-217, 2021-02-01 (Released:2021-02-01)
参考文献数
27
被引用文献数
3
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.

1 0 0 0 OA Approach to establishment of control strategy for oral solid dosage forms using continuous manufacturing

著者
Hayato Ishimoto Manabu Kano Hirokazu Sugiyama Hirofumi Takeuchi Katsuhide Terada Atsushi Aoyama Takuji Shoda Yosuke Demizu Jinen Shimamura Reiji Yokoyama Yuji Miyamoto Koji Hasegawa Masaru Serizawa Kazuomi Unosawa Kazuo Osaki Naochika Asai Yoshihiro Matsuda
出版者
The Pharmaceutical Society of Japan
雑誌
Chemical and Pharmaceutical Bulletin (ISSN:00092363)
巻号頁・発行日
pp.c20-00824, (Released:2020-12-08)
参考文献数
27
被引用文献数
3
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.