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

Susanne Pihl, Barry W. A. van der Strate, Michaela Golob, Laurent Vermet, Birgit Jaitner, Joanne Goodman, Marianne Scheel Fjording, Philip Timmerman*

*Bijbehorende auteur voor dit werk

OnderzoeksoutputAcademicpeer review

8 Citaten (Scopus)


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.

Originele taal-2English
Pagina's (van-tot)1557-1566
Aantal pagina's10
Nummer van het tijdschrift19
StatusPublished - okt-2018
Extern gepubliceerdJa

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