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ICCVAM Biennial Report 2014-2015

ICCVAM Biennial Report 2014-2015
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https://ntp.niehs.nih.gov/go/793728

Photosafety Testing

Photosafety testing is conducted to determine if a topically applied or systemically administered substance will cause a skin reaction after subsequent exposure to light. Traditionally, animals have been used to evaluate photosafety. ICCVAM agencies such as the U.S. Food and Drug Administration (FDA) are accepting alternative tests to reduce or replace animal use for photosafety testing.

ICCVAM and ICCVAM Agency Activities

  • FDA: In January 2015, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), of which FDA is a member, issued the guidance document “S10 Photosafety Evaluation of Pharmaceuticals.” The ICH guidance outlines details on when photosafety testing is warranted and on possible assessment strategies, including in vitro test methods that might be useful. The purpose of the guidance is to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals, and to avoid international duplication of studies.
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