12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.
Bioanalysis
; 11(12): 1129-1138, 2019 Jun.
Article
en En
| MEDLINE
| ID: mdl-31319683
ABSTRACT
The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Oligonucleótidos
/
Control Social Formal
/
Sociedades Científicas
/
Espectrometría de Masas
/
Certificación
/
Técnicas de Química Analítica
/
Citometría de Flujo
Tipo de estudio:
Diagnostic_studies
Idioma:
En
Revista:
Bioanalysis
Año:
2019
Tipo del documento:
Article
País de afiliación:
Estados Unidos