Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection

Research output: Contribution to journalJournal article

  • Steven W Baertschi
  • David Clapham
  • Chris Foti
  • Patrick J Jansen
  • Solveig Kristensen
  • Robert A Reed
  • Allen C Templeton
  • Hanne Hjorth Tønnesen

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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.
LanguageEnglish
JournalJournal of Pharmaceutical Sciences
Volume102
Issue number11
Pages (from-to)3888-99
Number of pages12
ISSN0022-3549
DOIs
StatePublished - 2013