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

Drug Discovery World

ISCT, the global society of clinicians, researchers, regulators, technologists, and industry partners dedicated to the translation of cell and gene therapy (CGT) into safe and effective therapies to improve patients’ lives, aligns with the FDA in support of the need for thorough investigation and transparency.

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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. Opiate-like effects of sugar on gene expression in reward areas of the rat brain. 2012;109(16):5984-5988. DOI: 10.1073/pnas.1120794109. 1120794109.

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