Application of manufacturing Classification System to manufacturing method selection for oral solid dosage forms in Japan-Reference-Cited by-同舟云学术

Application of manufacturing Classification System to manufacturing method selection for oral solid dosage forms in Japan

Published:2024-06 Issue:6 Volume:35 Page:104470
ISSN:0921-8831
Container-title:Advanced Powder Technology
language:en
Short-container-title:Advanced Powder Technology

Author:

Suzuki Hirofumi^ORCID,Takaishi Yuuki,Yoshimura Motoyasu,Hoshina Wataru,Shinogi Yoshiaki,Hisazumi Jin,Yamada Azumi,Sugie Yutaka^ORCID,Aikawa Shohei^ORCID,Yamada Rie,Quere Jean-Philippe,Mise Ryohei,Tahara Kohei^ORCID

Publisher

Elsevier BV

Reference22 articles.

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2. M. Leane, K. Pitt, G. K. Reynolds, N. Dawson, I. Ziegler, A. Szepes, A. M. Crean, R. D. Agnol and The Manufacturing Classification System (MCS) Working Group, Manufacturing classification system in the real world: factors influencing manufacturing process choices for filed commercial oral solid dosage drug products, case studies from industry and considerations for continuous processing, Pharm Dev Technol, (2018) DOI: 10. 1080/10837450. 2018. 1534863.

3. Proposed Pharmaceutical Manufacturing classification system (MCS) for oral solid dosage forms, Pharmaceuticals and Medical Devices Regulatory;Okazaki;Science,2020

4. Academic Symposium 5 Introduction to Manufacturing Classification System (MCS): The 36th Annual congress of the Japanese Society of Pharmaceutical Sciences, available at https://www. apstj. org/36/assets/pdf/apstj36_program_others. pdf(Link) (accessed on February 24, 2023).

5. International council for harmonisation (ICH), M9, Biopharmaceutics classification system-based biowaivers [Final version, adopted on November 20, 2019], available at https://database. ich. org/sites/default/files/M9_Guideline_Step4_2019_1116. pdf(Link) (accessed on February 24, 2023).