Technique requirements for in-use stability testing of drug products
CHEN Hai-feng
Abstract：The concept of in-use stability testing is introduced in this paper. The importance of in-use sta-bility testing for multidose drug products and/or products which needs constitution or dilution before use is empha-sized. Based on systemic analysis for the various key elements in requirements of in-use stability testing, we put forward EMEA and ICH guidelines. The main technique requirements are further explained with the examples of three drug products.
Keywords：in-use stability testingmultidose drug productsin-use period
Publication Date：2010-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 184-189 )