Reactive Oxygen Species Assay for Evaluating Phototoxicity Potential

Chapter

Abstract

The reactive oxygen species (ROS) assay was developed by Onoue and Tsuda (Analytical studies on the prediction of photosensitive/phototoxic potential of pharmaceutical substances. Pharm Res. 2006;23:156–64) and is a high-throughput, high-performance system for predicting the phototoxic potential of pharmaceutical substances. This assay has been proposed for use as a component in an integrated photosafety testing strategy to evaluate the phototoxicity potential of pharmaceuticals and other test substances. The reproducibility and predictivity of the ROS assay is sufficient to support its use in an integrated photosafety testing and decision strategy for drug research and development. In this strategy, negative results in the ROS assay would not require further testing in animals or other tests; positive, weakly positive, and inconclusive results would proceed to the next level of testing in an in vitro test system such as the 3T3 Phototoxicity Assay (OECD. Test Guideline 432), as accepted by ICH S10 in 2013. The use of the ROS assay could potentially provide significant savings in time, cost, and reduced animal use for photosafety assessments.

Keywords

Phototoxicity Photosafety ROS In vitro ICH 

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Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  1. 1.National Institute of Health Sciences (NIHS)TokyoJapan
  2. 2.Research and Development Center, Santen Pharmaceutical, Co., Ltd.OsakaJapan
  3. 3.The School of Pharmaceutical SciencesUniversity of ShizuokaShizuoka PrefectureJapan

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