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Microbial Status and Genetic Evaluation of Mice and Rats Proceedings of the 1999 US/Japan Conference (2000) / Chapter Skim
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Genetic Evaluation of Outbred Rats
Pages 47-50

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From page 47...
... We do have complete control data, including line listings, from the animals on the study. For example, if we have a particular question about vasculitis either in your breeding colony or from your source, we may request the historical response rate so that we can calculate whether there is a significant effect of the pharmaceutical in relation to variable background rates.
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From page 48...
... Currently, I participate in an International Life Sciences Institute group, which collects and attempts to compare across market-ready platforms in an effort to characterize platform responses. The purpose of this effort is to gain a similar experience base and even, in fact, build a standard response library to enable an understanding of what kind of toxic insult might reveal a predictable pattern.
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From page 49...
... We understand the importance of genetically engineered animals, but we do not necessarily appreciate that this importance can also apply to our standard toxicology models. Perhaps in the examples cited above, if we had the genetic information from the Japanese source of animals in the dose ranging study and the source for that carcinogenicity study, resulting linkage information may have enabled us to resurrect the validity of that study.
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From page 50...
... According to that 2-year assay, the doses were not selected properly for that group of animals, which means that we did not learn about the carcinogenic potential of the drug. If the rodent to human dose margin had been huge or the dose had been close to the appropriate dose, we probably would have been able to accept those data.
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Key Terms

  • control data
  • range finding
  • genetic markers
  • dose range
  • genetically engineered

  • microarray platform
  • background strains
  • predictable pattern
  • response rate
  • human dose

  • model expressed
  • emerging issues
  • accessory genes
  • study protocols
  • necessarily appreciate

  • typically receive
  • japanese source
  • drug evaluation
  • drug related
  • genetic marker

  • regarding genotype
  • experience base
  • issues regarding
  • knockout model
  • response characterization

  • marker information
  • technique similar
  • linkage information
  • toxic insult
  • standard response


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