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EBF recommendation on practical management of critical reagents for PK ligand-binding assays

Pihl, Susanne and van der Strate, Barry and Golob, Michaela and Vermet, Laurent and Jaitner, Birgit and Goodman, Joanne and Scheel Fjording, Marianne and Timmerman, Philip (2018) EBF recommendation on practical management of critical reagents for PK ligand-binding assays. Bioanalysis, 10 (19). pp. 1557-1565. ISSN 17576199

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.

Item Type: Article
Keywords: antibodies critical reagents ligand-binding assays major change minor change PK assay
Date Deposited: 02 Apr 2019 00:45
Last Modified: 02 Apr 2019 00:45
URI: https://oak.novartis.com/id/eprint/37242

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