Izutsu Ken-ichi

イヅツケンイチ | Izutsu Ken-ichi

Affiliation and department：
Job title： Professor

Research field (2)： Hygiene and public health (laboratory) , Pharmaceuticals - analytical and physicochemistry

Research keywords (7)： Generic Pharmaceuticals , Regulatory Science , Bioequivalence , タンパク質製剤 , 相分離 , 凍結乾燥 , Freeze-Drying

Research theme for competitive and other funds (3)：

製剤の高機能化
1.タンパク質凍結乾燥製剤の安定化 2.多成分系凍結水溶液の物性
1.Stabilization of Freeze-dried Protein Formulations 2.Characterization of Multi-solute frozen solutions

Papers (102)：

Hiroyuki Yoshida, Keita Teruya, Yasuhiro Abe, Takayuki Furuishi, Kaori Fukuzawa, Etsuo Yonemochi, Ken-ichi Izutsu. Effects of Glass Bead Size on Dissolution Profiles in Flow-through Dissolution Systems (USP 4). AAPS PharmSciTech. 2024. 25. 8
Ken-ichi Izutsu, Hiroyuki Yoshida, Yasuhiro Abe, Eiichi Yamamoto, Yoji Sato, Daisuke Ando. Application of the Thermal Analysis of Frozen Aqueous Solutions to Assess the Miscibility of Hyaluronic Acid and Polymers Used for Dissolving Microneedles. Pharmaceutics. 2024
Ando, D., Miyatsuji, M., Sakoda, H., Yamamoto, E., Miyazaki, T., Koide, T., Sato, Y., Izutsu, K.-I. Mechanical Characterization of Dissolving Microneedles: Factors Affecting Physical Strength of Needles. Pharmaceutics. 2024. 16. 2
Katsuhiko Hayashi, Kenji Ohya, Yutaka Kikuchi, Ken-Ichi Izutsu, Yukiko Hara-Kudo. Uniform Suspension of Heat-Killed Staphylococcus aureus for a Positive Control Used in the Monocyte-Activation Test. Biological & pharmaceutical bulletin. 2024. 47. 7. 1321-1325
Tokio Morita, Hiroyuki Yoshida, Yasuhiro Abe, Koji Tomita, Akihiko Nakamura, Chikako Hada, Chiyori Nakai, Keishi Kina, Makoto Takahashi, Nozomi Uemura, et al. Analysis of Factors Related to Variation in Dissolution Profiles Estimated from Continuously Conducted Dissolution Tests of Generic Products. Chemical and Pharmaceutical Bulletin. 2024. 72. 1. 28-35

ｍore...

MISC (43)：

Hiroaki Mamiya, Ken-Ichi Izutsu, Daichi Mitani. Draft Guideline for Industry to Manage Drug Shortages in Japan. Therapeutic innovation & regulatory science. 2024
伊豆津健一. レギュラトリーサイエンス教材ポイントシリーズ医薬品生物学的同等性の評価におけるバイオウェーバーと複雑な製剤の試験設定. PHARM TECH JAPAN. 2024. 40. 3. 530-534
IZUTSU Kenichi, MAMIYA Hiroaki, YOSHIDA Hiroyuki. Impact of Quality by Design (QbD)-Induced Changes in Manufacturing Control Methods on Prolonged Supply Interruptions of Non-conforming Pharmaceutical Products in Japan. Regulatory Science of Medical Products. 2024. 14. 3. 341-350
伊豆津健一, 間宮弘晃. The expected role of complex generic drugs in reducing the patient burden and promoting industries that utilize new technologies. Pharm Tech Japan. 2024. 40. 9
伊豆津健一, 小出達夫, 間宮弘晃, 佐藤陽治, 吉田寛幸. Stability-Related Supply Disruption of Generic Pharmaceuticals in Japan. レギュラトリーサイエンス学会誌. 2024. 14. 1. 91-105

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Education (2)：

Nagoya City University
Nagoya City University

Professional career (1)：

Ph.D.

Work history (10)：

2024/04 - 現在 International University of Health and Welfare School of Pharmacy at Narita Professor
2023/04 - 2024/03 International University of Health and Welfare School of Pharmacy Department of Pharmaceutical Sciences Professor
2022/06 - 2023/03 Osaka University Graduate School of Pharmaceutical Sciences
2018/06 - 2023/03 名古屋市立大学大学院薬学研究科客員教授(医薬品品質保証学分野)
2018/04 - 2023/03 National Institute of Health Sciences Division of Drugs Director

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Committee career (4)：

国立医薬品食品衛生研究所ジェネリック医薬品品質情報検討会委員
厚生労働省後発医薬品等の同等性試験ガイドライン検討連絡会議構成員
厚生労働省医薬品等行政評価・監視委員会委員
医薬品医療機器総合機構専門委員

Association Membership(s) (6)：

米国薬学会 , 日本薬剤学会 , 日本薬学会 , The Pharmaceutical Society of Japan , The Academy of Pharmaceutical Science and Technology , American Association of Pharmaceutical Scientists

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