study Nonclinical criteria required during vaccine development References Kijima, S., Yoshida, S. & Ochiai, Y. Activity and perspective on quantitative modeling and simulation in Japan: Update from the Pharmaceuticals and Medical Devices Agency. CPT Pharmacometrics (2022). 10.1002/psp4.12868 PubMed Asano J, Sato H, Hirakawa A. Practical basket design for binary outcomes with control of family-wise error rate. BMC Med Res Methodol 2023 Feb 27;23(1):52. 10.1186/s12874-023-01872-1. PubMed Kuribayashi, R., Nakano, A., Hariu, A., Kishioka, Y. & Honda, F. Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022. BioDrugs 37, 443-51 (2023). 10.1007/s40259-023-00605-6 PubMed Okumoto, A., Nomura, Y., Maki, K., Ogawa, T., Onodera, H., Shikano, M. & Okabe, N. Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention. Regul Toxicol Pharmacol 142, 105413 (2023). 10.1016/j.yrtph.2023.105413 PubMed Maruyama, Y., Sakurai, A., Noda, S., Fujiwara, Y., Okura, N., Takagi, T., Asano, J. & Honda, F. Regulatory Issues: PMDA - Review of Sakigake Designation Products: Oncolytic Virus Therapy with Delytact Injection (Teserpaturev) for Malignant Glioma. Oncologist 28, 664-70 (2023). 10.1093/oncolo/oyad041 PubMed Syst Pharmacol Topics Promotion of practical application of modeling and simulation in drug development Clinical study design with the control of overall type I error Approval and review of biosimilar products Review of regenerative products medical designated as SAKIGAKE products 14 11, 1552-5 PMDA disseminates information in various ways to promote scientific discussions and understanding of RS research conducted by PMDA. discussions with external experts. In FY2023, we held the 7th RS Workshop. The main contents are shown in Table 4 below. A total of 518 people attended (as registered participants) and through Q&A and panel discussion, active discussions were held on matters that require further scientific consideration, such as consideration based on international harmonization, the importance of cooperation with Asian countries, and estimation of efficacy, and we provided an opportunity to deepen the understanding of the content and significance of RS research in PMDA. We regularly hold RS workshops as a place for better understanding of RS research undertaken by PMDA through Table 4 < The 7th RS Workshop: https://www.pmda.go.jp/files/000265423.pdf > Dissemination of RS Information 3.3 Dissemination of RS information PMDA RS Workshop
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