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- W3023841025 endingPage "154" @default.
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- W3023841025 abstract "Genetic toxicity testing requirements for pharmaceutical agents is comprised of a set of short-duration in vitro and in vivo tests designed to characterize the potential of a clinical drug candidate to cause DNA damage. Such damage can go undetected in clinical trials, putting the safety of patients and volunteers at risk. Because the genetic toxicity tests are short in duration, relatively inexpensive, and have high predictivity for rodent carcinogens, these tests are used early in the drug development process. Since no single test can identify all types of DNA damage, a battery of tests is required prior to different phases of clinical trials. In addition to the required regulatory tests, genetic toxicity tests provide a useful early safety-screening tool to help select potential drug candidates in early drug discovery. In addition to understanding the genotoxic potential of drug candidates, potentially genotoxic impurities and metabolites also need to be characterized, as these may also represent a human health risk if not adequately controlled. The required genetic toxicity tests and several commonly used alternatives are described and the use of genetic toxicology throughout the drug development process from discovery through postmarketing is discussed." @default.
- W3023841025 created "2020-05-13" @default.
- W3023841025 creator A5073996373 @default.
- W3023841025 date "2017-01-01" @default.
- W3023841025 modified "2023-10-03" @default.
- W3023841025 title "Genetic Toxicology Testing" @default.
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