The 140th Annual Meeting of the Pharmaceutical Society of Japan (Kyoto)

Session information

Symposium

[S23] Toward the promotion of pediatric drug development in Japan-Challenges in medical practice and responses to international harmonization-

Fri. Mar 27, 2020 9:00 AM - 11:00 AM [Room D] Room D (1F)

Organizers: Takehisa Hanawa (Tokyo Univ of Science), Etsuo Yonemochi (Hoshi Univ), Tsutomu Harada (Showa Univ), Akimasa Yamatani (NCCHD), Yoshiteru Watanabe (Tohoku Medical and Pharmaceutical Univ)

With the advancement of medical care, the importance of personalized medical care is being advocated today, and the development of pharmaceutical technology that supports such medical care is also remarkable.
The dose of normally developed medicines is set for adults. However, it is often impossible for existing drugs to be administered to children, and in medical practice, the original preparation is processed into other dosage forms such as tablet crushing and capsule opening.
From an international perspective, the ICH E11 guidelines also advocate "development of pediatric drugs in parallel with the development of adult indications" and "implementation of appropriate clinical trials for pediatric dose setting". Therefore, the development of pediatric drugs has become a common issue globally, including Japan.
Therefore, this symposium promotes the development of pediatric preparations from the viewpoints of the current status of pediatric drug preparation in the medical field and the surrounding positions of doctors, pharmacists, pharmaceutical company developers, and regulatory science specialists. We would like to clarify the current situation and issues. This symposium is organized by members of then Clinical Formulation FG and Personalized Medicine FG in The Academy of Pharmaceutical Science and Technology, Japan,

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