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.
关键词
使用中稳定性/临床使用相容性/静脉注射/重组或稀释/临用现配药品
Key words
in-use stability testing/compatibility for clinical use/intravenous injection/reconstitution or dilution/ready-to-use drugs
维普
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