EBF recommendation on practical management of critical reagents for PK ligand-binding assays
Pihl, Susanne, van der Strate, Barry, Golob, Michaela, Vermet, Laurent, Jaitner, Birgit, Goodman, Joanne , 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 |
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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 |