[2022.12.23]
S.5002 - FDA Modernization Act 2.0 下院通過
[2022.12.16}
Zaher Nahle. A proof-of-concept study poised to remodel the drug development process. Front. Med. Technol., 16 December 2022. Sec. Pharmaceutical Innovation.
[2022.12.06}
Ewart, L., Apostolou, A., Briggs, S.A. et al. Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology. Commun Med 2, 154 (2022).
[2022.09.29]
S.5002 - FDA Modernization Act 2.0 上院通過
“(z) Nonclinical Test Defined.—For purposes of this section, the term ‘nonclinical test’ means a test conducted in vitro, in silico, or in chemico, or a non-human in vivo test that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug, and may include animal tests, or non-animal or human biology-based test methods, such as cell-based assays, microphysiological systems, or bioprinted or computer models.”.
Organ-on-a-chipを用いた各臓器の生理学的性質の再現により、Organ-on-a-chipの毒性試験、安全性試験への活用やバイオマーカーの同定等への活用が期待されています。
PEIJチップセンターにおいて、評価法の具体化等に資するOrgan-on-a-chipを活用した研究開発・試験及び我が国でその活用の促進が図られますよう、アカデミア、企業の皆様と協働いたします。
また、SMAに関する論文、Genetic screening of spinal muscular atrophy using a real-time modified COP-PCR technique with dried blood-spot DNA. Brain & Development、が、Brain & Development誌に受理されました[2017.04.19]。今後、同知見をOrgan-on-a-chipの開発に活かしてまいります。