Preclinical safety evaluation of human gene therapy products.

@article{Verdier1999PreclinicalSE,
  title={Preclinical safety evaluation of human gene therapy products.},
  author={F. J.-M. Verdier and Jacques Descotes},
  journal={Toxicological sciences : an official journal of the Society of Toxicology},
  year={1999},
  volume={47 1},
  pages={9-15}
}
Human gene therapy products include naked DNA and viral as well as non-viral vectors containing nucleic acids. There is limited experience on the preclinical toxicity studies necessary for the safety evaluation of these products, which have been outlined in several recently released guidelines. Requirements for the preclinical safety evaluation of human gene therapy products are both specific and non-specific. All key preclinical studies should be performed in compliance with Good Laboratory… CONTINUE READING

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