Photosafety Assessment of Pharmaceuticals

The design, execution, and interpretation of a photosafety program can be an unfamiliar aspect of drug development, in part because of the unfamiliarity with this topic in companies and the technical and scientific specialization required to perform these studies by contract research organizations (CRO). This chapter aims to provide a roadmap for the determination if a photosafety evaluation is required, and if so, how to proceed with the evaluation and subsequently, how to interpret the results. Throughout the chapter, real life experience is used to illustrate interpretation of results and how to address challenging results in these assays.