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. |
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| 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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| ISSN: | 1663-9812 |
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| DOI: | 10.3389/fphar.2025.1713471 |