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Challenges to Toxicity Testing

Challenges to Toxicity Testing in 21st Century

Toxicity testing of pharmaceutical drugs forms a critical part of the risk-benefit assessment that balances the beneficial effects of the drug against the observed toxic and adverse effects. Despite advances in toxicity assessment, many drugs and chemicals are marketed without adequate toxicology data.

The increasing demand for nonclinical safety data in the early phase of drug development has posed the following challenges to toxicology testing, which must be adequately addressed:

  • Demand for predictive screening assays to assess safety endpoints early in the drug development process, thereby reducing the attrition rate due to toxicity.
  • Need for medium to high output methods that enable parallel assessment of multiple compounds.
  • Adaptation of cutting-edge technologies like micro-sampling and in vivo imaging techniques like MRI and positron emission tomography (PET) in toxicology study protocols.
  • Identification of alternatives to the traditional in vivo toxicology study paradigm that utilizes rodent and/or non-rodent species.

Although there has been some progress in developing in vitro methods to screen for developmental toxicity, but still additional methods are required to improve the predictive capability of in vitro toxicity assays. This would not only enhance the accuracy of early safety assessment, but would also benefit efforts to replace animal testing.

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