Significance of Category Classification of Novel Medical Products Originated from Japanese Academic Researches with Regards to Its Industrialization
Author:
Affiliation:
1. Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences
Publisher
Japanese Society for Thermal Medicine
Link
https://www.jstage.jst.go.jp/article/thermalmed/37/1/37_25/_pdf
Reference8 articles.
1. 1) Classification of products as drugs and devices and additional product classification issues: guidance for industry and FDA staff. 2017. https://www.fda.gov/media/80384/download Accessed Jan 18, 2021
2. 2) Stern M.J., Solomonov K.V.V., Sazykina E., Schwartz A.J., Gad C.S., Goodrich P.G.: Initial evaluation of the safety of nanoshell-directed photothermal therapy in the treatment of prostate disease. Int J Toxicology, 35; 38-46, 2016.
3. 3) Rastinehad R.A., Anastos H., Wajswol E., Winoker S.J., Sfakianos P.J., Doppalapudi K.S., Carrick R.M., Knauer J.C., Taouli B., Lewis C.S., Tewari K.A., Schwartz A.J., Canfield E.S., George K.A., West L.J., Halas J.N.: Gold nanoshell-localized photothermal ablation of prostate tumors in a clinical pilot device study. PNAS, 116: 18590-18596, 2019.
4. 4) Shinkai M., Yanase M., Honda H., Wakabayashi T., Yoshida J., Kobayashi T.: Intracellular hyperthermia for cancer using magnetite cationic liposomes: in vitro study. Jpn J Cancer Res, 87: 1179-1183, 1996.
5. 5) Yanase M., Shinkai M., Honda H., Wakabayashi T., Yoshida J., Kobayashi T.: Intracellular hyperthermia for cancer using magnetite cationic liposomes: an in vivo study. Jpn J Cancer Res, 89: 463-469, 1998.
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