European Bioanalysis Forum recommendation on the best practices to demonstrate processed sample stability.
Bioanalysis
; 11(1): 7-11, 2019 Jan.
Article
en En
| MEDLINE
| ID: mdl-30475068
ABSTRACT
The European Bioanalysis Forum is providing a proposal on experiments to be conducted if processed samples are to be stored for a period of time, either after an initial injection or if processed samples are to be stored for a period of time prior to their first injection. Using survey information and extensive discussion an insight was gained as to whether the current practices employed during method validation were conducted to scientifically validate actual sample handling conditions or to simply meet a perceived regulatory expectation. The goal of this report is to recommend the adoption of scientifically justified validation experiments that exactly reproduce and processed test sample handling and storage procedures and to introduce some uniformity across the industry.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Proyectos de Investigación
/
Guías como Asunto
Tipo de estudio:
Guideline
País/Región como asunto:
Europa
Idioma:
En
Revista:
Bioanalysis
Año:
2019
Tipo del documento:
Article
País de afiliación:
Reino Unido