Discussion on the In-Use Stability Studying of Intravenous Drug Products
In-use stability of drug products can be described as how well a pharmaceutical product remains stable during in-use within a particular closure system.During the in-use period,the pharmaceutical product remains within its physical,chemical,and microbial specifications and retains its safety,efficacy,and performance.By discussing the current various technical guidelines and guidance documents published by the regulatory agencies or other international organizations on in-use stability,this paper discusses the design and focus of stability studies in intravenous drug and the technical points of concern,and puts forward corresponding suggestions.
in-use stability testingcompatibility for clinical useintravenous injectionreconstitution or dilutionready-to-use drugs
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维普
