Pihl Susanne, van der Strate Barry Wa, Golob Michaela, Vermet Laurent, Jaitner Birgit, Goodman Joanne, Fjording Marianne Scheel, Timmerman Philip
Susanne Pihl, Ascendis Pharma A/S, Copenhagen, Denmark.
PRA Health Sciences, Assen, The Netherlands.
Bioanalysis. 2018 Oct 1;10(19):1557-1565. doi: 10.4155/bio-2018-0230. Epub 2018 Sep 18.
Critical reagents play a crucial role in ligand-binding assays; the robustness and reliability of an assay is defined by the quality and long-term availability of these reagents. However, neither regulatory guidelines nor relevant scientific papers provide clear directions for set-up, life cycle management and, more importantly, the acceptance criteria required for the testing of the critical reagents for pharmacokinetic, biomarker and immunogenicity assays. The ambiguity from current guidelines can be a challenge for the bioanalytical community. Members of the European Bioanalysis Forum community undertook a more pragmatic approach on how to assess the impact of critical reagents. In this paper, a review and corresponding gap analysis of the current guidelines and relevant papers will be provided as well as decision trees proposed for lot-to-lot changes of critical reagents for pharmacokinetic assays.
关键试剂在配体结合分析中起着至关重要的作用；分析方法的稳健性和可靠性取决于这些试剂的质量和长期可得性。然而，无论是监管指南还是相关科学论文，都没有为药代动力学、生物标志物和免疫原性分析中关键试剂的设置、生命周期管理，更重要的是测试所需的验收标准提供明确的指导。当前指南的模糊性对生物分析领域来说可能是一个挑战。欧洲生物分析论坛的成员对如何评估关键试剂的影响采取了更务实的方法。本文将对当前指南和相关论文进行综述及相应的差距分析，并提出药代动力学分析中关键试剂批次间变更的决策树。
