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. 2018 Oct 1;10(19):1557-1565.
doi: 10.4155/bio-2018-0230. Epub 2018 Sep 18.

EBF Recommendation on Practical Management of Critical Reagents for PK Ligand-Binding Assays

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EBF Recommendation on Practical Management of Critical Reagents for PK Ligand-Binding Assays

Susanne Pihl et al. Bioanalysis. .

Abstract

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.

Keywords: PK assay; antibodies; critical reagents; ligand-binding assays; major change; minor change.

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