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

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

Publikation: Bidrag til tidsskriftKommentar/debatForskningpeer review

Abstrakt

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.
OriginalsprogEngelsk
TidsskriftJournal of Pharmaceutical Sciences
Vol/bind102
Udgave nummer11
Sider (fra-til)3888-3899
Antal sider12
ISSN0022-3549
DOI
StatusUdgivet - nov. 2013

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