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Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.

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Title: Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.
Authors: Fukaya-Shiba A; Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Ogata A; Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Kuribayashi R; Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Office of Regulatory Science Research, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Sakurai A; Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Suzuki K; Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Takadama S; Office of New Drug IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Nishimura J; Office of New Drug IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan., Uchiyama J; Department of Bacteriology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan., Ohge H; Department of Infectious Diseases, Hiroshima University Hospital, Hiroshima, Japan., Takeuchi T; Pathogen Genomics Center, National Institute of Infectious Diseases, Japan Institute for Health Security, Tokyo, Japan., Tamaki H; Biomanufacturing Process Research Center, National Institute of Advanced Industrial Science and Technology, Ibaraki, Japan., Matsumoto T; Department of Infectious Diseases, International University of Health and Welfare, Chiba, Japan., Kiga K; Department of Drug Development, National Institute of Infectious Diseases, Japan Institute for Health Security, Tokyo, Japan., Iwano H; Laboratory of Veterinary Biochemistry, Rakuno Gakuen University School of Veterinary Medicine, Hokkaido, Japan.
Source: Frontiers in pharmacology [Front Pharmacol] 2025 Dec 18; Vol. 16, pp. 1713471. Date of Electronic Publication: 2025 Dec 18 (Print Publication: 2025).
Publication Type: Journal Article
Journal Info: Publisher: Frontiers Media] Country of Publication: Switzerland NLM ID: 101548923 Publication Model: eCollection Cited Medium: Print ISSN: 1663-9812 (Print) Linking ISSN: 16639812 NLM ISO Abbreviation: Front Pharmacol Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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  Data: Regulatory considerations for developing phage therapy medicinal products for the treatment of antimicrobial resistant bacterial infections.
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  Data: <searchLink fieldCode="AU" term="%22Fukaya-Shiba+A%22">Fukaya-Shiba A</searchLink>; Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Ogata+A%22">Ogata A</searchLink>; Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Kuribayashi+R%22">Kuribayashi R</searchLink>; Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.; Office of Regulatory Science Research, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Sakurai+A%22">Sakurai A</searchLink>; Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Suzuki+K%22">Suzuki K</searchLink>; Office of Regulatory Science Coordination, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Takadama+S%22">Takadama S</searchLink>; Office of New Drug IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Nishimura+J%22">Nishimura J</searchLink>; Office of New Drug IV, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Uchiyama+J%22">Uchiyama J</searchLink>; Department of Bacteriology, Graduate School of Medicine Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan.<br /><searchLink fieldCode="AU" term="%22Ohge+H%22">Ohge H</searchLink>; Department of Infectious Diseases, Hiroshima University Hospital, Hiroshima, Japan.<br /><searchLink fieldCode="AU" term="%22Takeuchi+T%22">Takeuchi T</searchLink>; Pathogen Genomics Center, National Institute of Infectious Diseases, Japan Institute for Health Security, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Tamaki+H%22">Tamaki H</searchLink>; Biomanufacturing Process Research Center, National Institute of Advanced Industrial Science and Technology, Ibaraki, Japan.<br /><searchLink fieldCode="AU" term="%22Matsumoto+T%22">Matsumoto T</searchLink>; Department of Infectious Diseases, International University of Health and Welfare, Chiba, Japan.<br /><searchLink fieldCode="AU" term="%22Kiga+K%22">Kiga K</searchLink>; Department of Drug Development, National Institute of Infectious Diseases, Japan Institute for Health Security, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Iwano+H%22">Iwano H</searchLink>; Laboratory of Veterinary Biochemistry, Rakuno Gakuen University School of Veterinary Medicine, Hokkaido, Japan.
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  Data: <searchLink fieldCode="JN" term="%22101548923%22">Frontiers in pharmacology</searchLink> [Front Pharmacol] 2025 Dec 18; Vol. 16, pp. 1713471. <i>Date of Electronic Publication: </i>2025 Dec 18 (<i>Print Publication: </i>2025).
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