Perspectives on updates, clarifications and controversies in chromatographic assay guidance for bioanalytical method validation from major regulatory agencies and organizations.
Biomed Chromatogr
; 35(1): e5030, 2021 Jan.
Article
de En
| MEDLINE
| ID: mdl-33201529
ABSTRACT
Bioanalysis, a key supporting function for generating data for pre-clinical and clinical studies in drug development, is under the regulation of local agencies as well as global organizations to ensure the data integrity and quality in submission. As major regulatory agencies and organizations, the US Food and Drug Administration, the European Medicines Agency and the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use have been updating their industry guidance for bioanalytical method validation, to keep up with the development new modalities, technologies and regulations. This article summarizes the recent updates and any clarifications and controversies triggered by those updates. Perspectives and recommendations are given based on our own experience as well as commonly accepted practice in the bioanalytical community.
Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Chimie pharmaceutique
/
Chromatographie
Type d'étude:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Limites:
Humans
Pays/Région comme sujet:
America do norte
Langue:
En
Journal:
Biomed Chromatogr
Année:
2021
Type de document:
Article
Pays d'affiliation:
États-Unis d'Amérique