Incurred sample reproducibility: 10 years of experiences: views and recommendations from the European Bioanalysis Forum.
Bioanalysis
; 10(21): 1723-1732, 2018 Nov 01.
Article
en En
| MEDLINE
| ID: mdl-30412676
ABSTRACT
With 10 years of experiences on incurred sample reanalysis (ISR) as an integrated part of regulated bioanalysis, the European Bioanalysis Forum has reflected on the implementation and the use of ISR. Three surveys were conducted in 2016 and 2017 as a revisit of the ISR experiences within European pharmaceutical industry and contract research organizations has ISR become a tool for postvalidation and process check of a bioanalytical method performance and has ISR become a routine in our laboratories? Do we agree on the interpretation of guidelines/guidance and are we aligned in our approach - among others?
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Control de Calidad
/
Reproducibilidad de los Resultados
/
Industria Farmacéutica
/
Desarrollo de Medicamentos
Tipo de estudio:
Prognostic_studies
/
Qualitative_research
Límite:
Animals
/
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Bioanalysis
Año:
2018
Tipo del documento:
Article
País de afiliación:
Dinamarca