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Expert consortium comment on FDA report on risk of T-cell malignancy  

Drug Discovery World

These therapies, which exhibit substantial long-term side effects, including genotoxicity and an increased predisposition to secondary cancers, have significantly higher rates of subsequent malignancies than the rate reported for patients following CAR-T cell immunotherapies.

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Genotoxicity Testing: Unlocking the Future Safety Assessment Opportunities

Roots Analysis

Genotoxicity testing refers to the evaluation of detrimental effects of chemical or physical agents on the genetic processes and related hereditary material of living cells. Mechanism of Genotoxicity / Mutagenicity The interaction of genotoxins / mutagens with the structure of DNA causes damage to the genetic material.

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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issues guidelines and develops testing strategies for evaluating carcinogenicity along with other risks such as genotoxicity, immunotoxicity, and reproductive toxicity. Toxicologic Pathology. 2011;39(4):716-744.

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Let's Quit Sugar With Audiobook – Let's Quit Sugar

The Pharma Data

Exposure to sorbitol during lactation causes metabolic alterations and genotoxic effects in rat offspring. Neural and Genetic Correlates of the Social Sharing of Happiness. Proceedings of the National Academy of Sciences of the United States of America. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109. Toxicol Lett.

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