SOCIAL QUESTIONS|health|pharmaceutical industry · PRODUCTION, TECHNOLOGY AND RESEARCH|technology and technical regulations|biotechnology
- staidéar bithdháileacháin Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
- ga
- biodistribution study | BD study | nonclinical BD study | non-clinical BD study | bio-distribution study | bio-distribution studies
- en
- Sainmhíniú assessment of adverse events arising from the risk factors specific to cell therapies (survival/engraftment, proliferation, differentiation, migration, and tumorigenicity, and the efficacy of the products) as well as of the doses and the method (route) of administration Tagairt "COM-Terminology Coordination, based on: Kamiyama Y, Naritomi Y, Moriya Y, Yamamoto S, Kitahashi T, Maekawa T, Yahata M, Hanada T, Uchiyama A, Noumaru A, Koga Y, Higuchi T, Ito M, Komatsu H, Miyoshi S, Kimura S, Umeda N, Fujita E, Tanaka N, Sugita T, Takayama S, Kurogi A, Yasuda S, Sato Y. 'Biodistribution studies for cell therapy products: Current status and issues' (24.2.2023). Regenerative Therapy 2021 Jul 12;18:202-216. doi: 10.1016/j.reth.2021.06.005. PMID: 34307798; PMCID: PMC8282960."
- Nóta BD studies can be conducted as stand-alone BD studies or in conjunction with nonclinical pharmacology and toxicology studies.