The 145th Annual Meeting of the Pharmaceutical Society of Japan (Fukuoka)
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Session Details

Oral Presentation(E) Pharmaceutical Health Care and Sciences

[28-14-am]Regulatory Science

Fri. Mar 28, 2025 8:30 AM - 9:42 AM JST
Fri. Mar 28, 2025 11:30 PM - 12:42 AM UTC
Room 14 (Fukuoka International Congress Center: 405+406 [4F])
Chair: Yukiko Ogawa, Yuichi Muraki
8:30 AM - 8:42 AM JST(11:30 PM - 11:42 PM UTC)

[28-14-am01S]Mono-scaled benefit/risk analysis in the advanced countries of HPV vaccination

○Miwa Satake1, Naoki Matsumaru1, Katsura Tsukamoto1 (1. Gifu Pharm. Univ.)
8:42 AM - 8:54 AM JST(11:42 PM - 11:54 PM UTC)

[28-14-am02S]Comparison of anti-drug antibody assay using Etanercept reference product or biosimilar

○Eriko Okamoto1, Aoi Nakayama2, Kodai Yajima1, Sho Masui1,2, Akira Onishi3, Masahiro Tsuda2, Tomohiro Terada2, Atsushi Yonezawa1,2 (1. Fac. Pharm., Keio Univ., 2. Kyoto Univ. Hosp., 3. Fac. Med., Kyoto Univ.)
8:54 AM - 9:06 AM JST(11:54 PM - 12:06 AM UTC)

[28-14-am03S]Comparison of Regulatory Reviews for Lecanemab in Japan, the US, and Europe

○Daichi Kyuragi1, Hiromichi Kirihara2, Ayaka Tsukai1, Yuki Niwa2, Masuo Kondoh2 (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ.)
9:06 AM - 9:18 AM JST(12:06 AM - 12:18 AM UTC)

[28-14-am04S]Characterization of CYP3A4-expressing Caco-2 cells as a system for evaluation of intestinal barrier modulators

○Shu Miyoshi1, lin Bai2, Shuko Sakimura1, Yuki Niwa2, Hiroyuki Mizuguchi2,3,4,5,6, Masuo Kondou2 (1. F. Pharm. Sci., Osaka Univ, 2. Grad. Sch. Pharm. Sci., Osaka Univ., 3. NIBIOHN, 4. OTRI, Osaka Univ., 5. MEI cent., Osaka Univ., 6. CiDER, Osaka Univ.)
9:18 AM - 9:30 AM JST(12:18 AM - 12:30 AM UTC)

[28-14-am05S]Pediatric-specific drug loss issue in Japan: Comparison of pediatric drug development status between Japan and the United States

○Ryohei Osako1, Mami Takemura1, Naoki Matsumaru1, Katsura Tsukamoto1 (1. Gifu Pharmaceutical University)
9:30 AM - 9:42 AM JST(12:30 AM - 12:42 AM UTC)

[28-14-am06]Corporate Policy Changes Following Q&A on Sales Guidelines for Ethical Drugs

○Katsunori Yamaura1, Ririka Mima1, Shingo Kondo1, Hiroki Iwata1, Noriko Kobayashi1, Shinichi Watanabe2 (1. Keio Univ. Faculty Pharm., 2. Teikyo Heisei Univ. Faculty Pharm.)
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