EBF recommendation on practical management of critical reagents for PK ligand-binding assays.
Bioanalysis
; 10(19): 1557-1565, 2018 Oct 01.
Article
en En
| MEDLINE
| ID: mdl-30226086
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.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Indicadores y Reactivos
Tipo de estudio:
Guideline
/
Prognostic_studies
País/Región como asunto:
Europa
Idioma:
En
Revista:
Bioanalysis
Año:
2018
Tipo del documento:
Article
País de afiliación:
Dinamarca