Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team
Ligand Binding Assay Critical Reagents and Their Stability: Recommendations and Best Practices from the Global Bioanalysis Consortium Harmonization Team
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配体结合测定关键试剂及其稳定性：全球生物分析联盟协调团队的建议和最佳实践
作者：
L. King;Esme Farley;Mami Imazato;Jeannine Keefe;M. Khan;M. Ma;K. Pihl;P. Sriraman
L4 全球试剂及其稳定性协调团队专注于药代动力学、免疫原性和生物标志物配体结合测定的关键试剂的管理。监管指南认识到试剂对于配体结合测定很重要，但没有解决关键试剂生命周期管理的许多方面。试剂可以从外部供应商获得或内部开发，但无论其来源如何，其可靠的长期使用都有许多考虑因素。作者确定了当前的最佳实践，并为关键试剂批次变更、稳定性管理和文档提供了建议。
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.