FDA Finalizes Photosafety Testing Guidance
Saturday, February 7, 2015
Source: FDA News
The FDA emphasized flexibility in a final guidance that attempts to harmonize U.S. and International Conference on Harmonisation drug photosafety testing requirements.
If the compound in question is poorly soluble, for example, drugmakers may not find it appropriate to conduct an in vitro assay and may choose an animal or human assessment.
If the in vitro test is positive, drugmakers could consider conducting a phototoxicity study in animals to see if the same results come up in vivo — unless existing use information can support a case for low risk of phototoxicity.