Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group.
Clin Pharmacol Ther
; 115(5): 939-953, 2024 May.
Article
en En
| MEDLINE
| ID: mdl-38073140
ABSTRACT
The intent of this perspective is to share the recommendations of the International Consortium for Innovation and Quality in Pharmaceutical Development Metabolite Bioanalysis Working Group on the fit-for-purpose metabolite bioanalysis in support of drug development and registration. This report summarizes the considerations for the trigger, timing, and rigor of bioanalysis in the various assessments to address unique challenges due to metabolites, with respect to efficacy and safety, which may arise during drug development from investigational new drug (IND) enabling studies, and phase I, phase II, and phase III clinical trials to regulatory submission. The recommended approaches ensure that important drug metabolites are identified in a timely manner and properly characterized for efficient drug development.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Informe de Investigación
/
Desarrollo de Medicamentos
Límite:
Humans
Idioma:
En
Revista:
Clin Pharmacol Ther
Año:
2024
Tipo del documento:
Article
País de afiliación:
Estados Unidos