Recommendations for singlet-based approach in ligand binding assays: an IQ Consortium perspective.
Bioanalysis
; 12(12): 823-834, 2020 Jun.
Article
em En
| MEDLINE
| ID: mdl-32558588
ABSTRACT
Historically, ligand-binding assays for pharmacokinetic samples employed duplicate rather than singlet-based analysis. Herein, the Translational and absorption, distribution, metabolism and excretion (ADME) Sciences Leadership Group of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) presents a study aiming to determine the value of duplicate versus singlet-based testing. Based on analysis of data collected from eight organizations for 20 drug candidates representing seven molecular types and four analytical platforms, statistical comparisons of validation and in-study quality controls and study unknown samples demonstrated good agreement across duplicate sets. Simulation models were also used to assess the impact of sample duplicate characteristics on bioequivalence outcomes. Results show that testing in singlet is acceptable for assays with %CV ≤15% between duplicates. Singlet-based approach is proposed as the default for ligand-binding assays while a duplicate-based approach is needed where imprecision and/or inaccuracy impede the validation of the assay.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Controle de Qualidade
/
Preparações Farmacêuticas
Tipo de estudo:
Prognostic_studies
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Estados Unidos