[28V09-pm] レギュラトリーサイエンス（医薬品等）

Sun. Mar 28, 2021 2:27 PM - 3:51 PM [Room V09] Oral Presentation 9 (Online)

座長：山浦克典（慶應大薬）、田口真穂（横浜薬大）

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2:27 PM - 2:39 PM

[28V09-pm07] Survey on the labeling of allergens contained in pharmaceutical products in Australia

○Shinobu Sakai¹, Naohiro Oshima¹, Maiko Tahara¹, Eiichi Yamamoto¹, Tamaki Miyazaki¹, Daisuke Ando¹, Ken-ichi Izutsu¹, Reiko Adachi¹, Reiko Teshima², Junko Komura³, Yoshiaki Ikarashi¹ (1. NIHS, 2. Faculty of Vet. Med., Okayama Univ. of Science, 3. Faculty of Pharm. Sci., Setsunan Univ.)

2:39 PM - 2:51 PM

[28V09-pm08S] Validation of Mathematical Model for Benefit-Risk Assessment on Human Papillomavirus vaccine

○Manami Inoue¹, Tomoko Matsumoto², Naoki Matsumaru¹, Katsura Tsukamoto¹ (1. Gifu Pharmaceutical Univ., 2. Syneos Health Clinical)

2:51 PM - 3:03 PM

[28V09-pm09S] Regulatory science of absorption enhancers for bicellular and tricellular tight junctions

○Sayaka Sugimura¹, Keisuke Tachibana², Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ.)

3:03 PM - 3:15 PM

[28V09-pm10S] A regulatory concept of pharmacokinetics for precision medicine: lesson from microbiome and the dossiers of new drug approvals

○Makiko Sho¹, Keisuke Tachibana², Syohei Ota¹, Kazuo Harada², Kazumasa Hirata², Yasuo Tsutsumi², Jun Kunisawa^2,3,4,5,6,7, Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ., 3. NIBIOHN, 4. Grad. Sch. Med., Pharm. Sci., Dent., Osaka Univ., 5. Grad. Sch. Med., Kobe Univ., 6. Inst. Med. Sci., Univ. Tokyo, 7. Research Organization for Nano & Life Innovation, Waseda Univ.)

3:15 PM - 3:27 PM

[28V09-pm11S] Current status and regulatory issues for interoperable medical devices and systems

○Kazuma Ishimoto¹, Keisuke Tachibana², Toshikatsu Washio³, Tatsuhiko Arafune⁴, Masuo Kondoh² (1. Sch Pharm Sci., Osaka Univ., 2. Grad Sch Pharm Sci., Osaka Univ., 3. Health Research Institute, AIST, 4. Sch Sci Eng., Tokyo Denki Univ.)

3:27 PM - 3:39 PM

[28V09-pm12S] A reverse regulatory science: regulatory consideration for development of a pharmaceutical platform for central nervous system drugs

○Itsuki Nishino¹, Yumi Iwashita², Keisuke Tachibana², Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ.)

3:39 PM - 3:51 PM

[28V09-pm13S] A reverse regulatory science: regulatory consideration for development of anti-dementia drug

○taiki nishikaji¹, Erika Wakayama¹, Keisuke Tachibana², Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ.)

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