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Report of the international conference on regulatory endeavors towards the sound development of human cell therapy products.
Hayakawa T, Aoi T, Bravery C, Hoogendoorn K, Knezevic I, Koga J, Maeda D, Matsuyama A, McBlane J, Morio T, Petricciani J, Rao M, Ridgway A, Sato D, Sato Y, Stacey G, Sakamoto N, Trouvin JH, Umezawa A, Yamato M, Yano K, Yokote H, Yoshimatsu K, Zorzi-Morre P. Hayakawa T, et al. Biologicals. 2015 Sep;43(5):283-97. doi: 10.1016/j.biologicals.2015.07.009. Epub 2015 Aug 24. Biologicals. 2015. PMID: 26315651
Report of the International Regulatory Forum on Human Cell Therapy and Gene Therapy Products.
Hayakawa T, Harris I, Joung J, Kanai N, Kawamata S, Kellathur S, Koga J, Lin YC, Maruyama Y, McBlane J, Nishimura T, Renner M, Ridgway A, Salmikangas P, Sakamoto N, Sato D, Sato Y, Toda Y, Umezawa A, Werner M, Wicks S. Hayakawa T, et al. Biologicals. 2016 Sep;44(5):467-79. doi: 10.1016/j.biologicals.2016.06.002. Epub 2016 Jul 22. Biologicals. 2016. PMID: 27461129
Tumorigenicity assessment of cell therapy products: The need for global consensus and points to consider.
Sato Y, Bando H, Di Piazza M, Gowing G, Herberts C, Jackman S, Leoni G, Libertini S, MacLachlan T, McBlane JW, Pereira Mouriès L, Sharpe M, Shingleton W, Surmacz-Cordle B, Yamamoto K, van der Laan JW. Sato Y, et al. Among authors: mcblane jw. Cytotherapy. 2019 Nov;21(11):1095-1111. doi: 10.1016/j.jcyt.2019.10.001. Epub 2019 Nov 9. Cytotherapy. 2019. PMID: 31711733 Free article. Review.
19 results