Principles for Evaluating the Efficacy and Safety of Ceramic Dental Implants in Japan.

Autor: Hara T; Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.; Department of Oral Implantology, Osaka Dental University, Osaka, 573-1121, Japan.; Healthy Policy Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan., Sato Y; Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan., Tanishiro H; Translational Research Institute for Medical Innovation, Osaka Dental University, Osaka, 573-1121, Japan., Tamaki Y; Department of Dental Materials Science, Division of Oral Functional Science and Rehabilitation, Asahi University School of Dentistry, Gifu, 501-0296, Japan., Baba S; Department of Oral Implantology, Osaka Dental University, Osaka, 573-1121, Japan., Hirose E; Japan Association of Dental Implant Suppliers, Tokyo, 108-0014, Japan., Yoshida B; Japan Dental Materials Manufacturers Association, Tokyo, 111-0056, Japan., Watanabe K; Japan Dental Materials Manufacturers Association, Tokyo, 111-0056, Japan., Nishikawa G; Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan., Okuda D; Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.; Japan Agency for Medical Research and Development, Tokyo, 100-0004, Japan., Murakami M; Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Tokyo, 100-8916, Japan.; Office of Software as a Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan., Niwa Y; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, 567-0871, Japan., Kondoh M; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, 567-0871, Japan. masuo@phs.osaka-u.ac.jp.

Publikováno v: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Nov 05. Date of Electronic Publication: 2024 Nov 05.

Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical Devices.

Autor: Ishibashi K; Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. ishibashi-kenichi@pmda.go.jp., Kondoh M; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan., Kusakabe T; Japan Agency for Medical Research and Development, Tokyo, Japan. tetsuya-kusakabe@amed.go.jp.

Publikováno v: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Nov; Vol. 58 (6), pp. 1172-1179. Date of Electronic Publication: 2024 Aug 30.

Modifying the blood-brain barrier by targeting claudin-5: Safety and risks.

Autor: Wakayama E; Faculty of Pharmaceutical Sciences, Osaka University, Osaka, Japan., Kuzu T; College of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, Japan.; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan., Tachibana K; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan., Hirayama R; Graduate School of Medicine, Osaka University, Osaka, Japan., Okada Y; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan., Kondoh M; Graduate School of Pharmaceutical Sciences, Osaka University, Osaka, Japan.

Publikováno v: Annals of the New York Academy of Sciences [Ann N Y Acad Sci] 2022 Aug; Vol. 1514 (1), pp. 62-69. Date of Electronic Publication: 2022 May 04.

Association of Plasma Claudin-5 with Age and Alzheimer Disease.

Autor: Tachibana K; Graduate School of Pharmaceutical Sciences, Osaka University, Suita 565-0871, Osaka, Japan., Hirayama R; Graduate School of Medicine, Osaka University, Suita 565-0871, Osaka, Japan., Sato N; Graduate School of Medicine, Osaka University, Suita 565-0871, Osaka, Japan.; Department of Aging Neurobiology, Center for Development of Advanced Medicine for Dementia, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan., Hattori K; Department of Bioresources, Medical Genome Center, National Center of Neurology and Psychiatry, Kodaira 187-8551, Tokyo, Japan., Kato T; Department of Clinical and Experimental Neuroimaging, National Center for Geriatrics and Gerontology, Obu 474-8511, Aichi, Japan., Takeda H; Proteo-Science Center, Ehime University, Matsuyama 790-8577, Ehime, Japan., Kondoh M; Graduate School of Pharmaceutical Sciences, Osaka University, Suita 565-0871, Osaka, Japan.

Publikováno v: International journal of molecular sciences [Int J Mol Sci] 2024 Jan 24; Vol. 25 (3). Date of Electronic Publication: 2024 Jan 24.

Synthetic model ecosystem of 12 cryopreservable microbial species allowing for a noninvasive approach.

Autor: Hosoda K; RIKEN Center for Biosystems Dynamics Research, 6-2-3 Furuedai, Suita, Osaka, 565-0874, Japan; Center for Information and Neural Networks (CiNet), National Institute of Information and Communications Technology (NICT), Osaka, Japan; Institute for Transdisciplinary Graduate Degree Programs, Osaka University, 1-5 Yamadaoka, Suita, Osaka, 565-0871, Japan; Life and Medical Sciences Area, Health Sciences Discipline, Kobe University, Tomogaoka 7-10-2, Suma-ku, Kobe, Hyogo, 654-0142, Japan. Electronic address: hosodak@nict.go.jp., Seno S; Graduate School of Information Science and Technology, Osaka University, 1-5 Yamadaoka, Suita, Osaka, 565-0871, Japan., Murakami N; RIKEN Center for Biosystems Dynamics Research, 6-2-3 Furuedai, Suita, Osaka, 565-0874, Japan., Matsuda H; Graduate School of Information Science and Technology, Osaka University, 1-5 Yamadaoka, Suita, Osaka, 565-0871, Japan., Osada Y; Graduate School of Life Sciences, Tohoku University, 6-3 Aoba, Aramaki, Aoba-ku, Sendai, 980-8578, Japan., Kamiura R; RIKEN Center for Biosystems Dynamics Research, 6-2-3 Furuedai, Suita, Osaka, 565-0874, Japan., Kondoh M; Graduate School of Life Sciences, Tohoku University, 6-3 Aoba, Aramaki, Aoba-ku, Sendai, 980-8578, Japan. Electronic address: michio.kondo.b8@tohoku.ac.jp.

Publikováno v: Bio Systems [Biosystems] 2024 Jan; Vol. 235, pp. 105087. Date of Electronic Publication: 2023 Nov 19.