期刊
AAPS JOURNAL
卷 16, 期 3, 页码 504-515出版社
SPRINGER
DOI: 10.1208/s12248-014-9583-x
关键词
critical reagents; ligand binding assays; lot changes; recommendations; stability
The L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation.
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