Photosafety

摘要: Photosafety testing is an important component in preclinical drug development, but one that not well understood as to the accepted methodologies, when initiate evaluation, expectations of regulatory agencies, and how interpret results. The lack clarity current guidances, controversy over interpretation vitro assays absence formally-validated/accepted vivo have affected ability clearly understand evaluate photosafety a discovery program. Experience with test models, borne experience, does allow for evaluation phototoxic potential drugs chemicals, ambiguity remains. Over past five years, serious efforts address this uncertainty been initiated further work needed critically and, necessary, refine methods, propose new methods state expectations. However,