Baertschi, Steven W3; Clapham, David4; Foti, Chris4; Jansen, Patrick J4; Kristensen, Solveig4; Reed, Robert A4; Templeton, Allen C4; Tønnesen, Hanne Hjorth5
1 Sygehus Sønderjylland, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU2 Center Sønderjylland, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU3 Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, Indiana, 46285.4 unknown5 Sygehus Sønderjylland, Institute of Regional Health Research, Det Sundhedsvidenskabelige Fakultet, SDU
proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection
Basic guidance on the photostability testing of pharmaceuticals, designed to cover manufacturing and storage over shelf life, has long been established within ICH Q1(ICH,B(10) , but the guideline does not cover the photostability of drugs during or after administration (i.e., under conditions of use). To date, there has been a paucity of guidance covering the additional testing that would be of value during the clinical preparation and use of products. This commentary suggests a systematic approach, based on realistic "worst case" photoexposure scenarios and the existing ICH Option 1 and 2 light sources, to provide valuable data to pharmaceutical manufacturers and compounding pharmacists for the safe and effective use of photosensitive injection products.
Journal of Pharmaceutical Sciences, 2013, Vol 102, Issue 11, p. 3888-99