Domestic and International Trends in Non-Clinical Safety Evaluation of Cell Therapy Products
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- SATO Yoji
- Division of Cell-Based Therapeutic Products, National Institute of Health Sciences
Bibliographic Information
- Other Title
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- 細胞加工製品の非臨床安全性評価に関する国内外の状況
Abstract
<p>Cell therapy products (CTPs) are a new pharmaceutical modality containing living cells. The risk of tumorigenesis derived from cells in the product is one of the major concerns specific to CTPs, and appropriate test methods must be developed as needed. A variety of highly sensitive detection methods for tumorigenic cells as impurities of CTPs have been developed in Japan, some of which have been validated through a public-private joint research (MEASURE). The need for global consensus on the tumorigenicity assessment of CTPs is also discussed at an international consortium (HESI CT-TRACS). </p>
Journal
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- Annual Meeting of the Japanese Society of Toxicology
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Annual Meeting of the Japanese Society of Toxicology 48.1 (0), S27-1-, 2021
The Japanese Society of Toxicology
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Details 詳細情報について
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- CRID
- 1390570486221109760
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- NII Article ID
- 130008073896
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- Text Lang
- ja
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- Data Source
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- JaLC
- CiNii Articles
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- Abstract License Flag
- Disallowed