The effectiveness of quality control samples in pharmaceutical bioanalysis.
Bioanalysis
; 13(3): 135-145, 2021 Feb.
Article
em En
| MEDLINE
| ID: mdl-33538614
ABSTRACT
The use of quality control (QC) samples in bioanalysis is well established and consistent with regulatory guidance. However, a systematic evaluation of whether QC samples serve the intended purpose of improving data quality has not been undertaken. The Translational and ADME Sciences Leadership Group (TALG) of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) conducted an evaluation to assess whether closer agreement is observed when comparing pharmacokinetic data from two passed runs, than when comparing data from failed and passed (retest) runs. Analysis of data collected across organizations, molecular types and analytical platforms, revealed that bioanalytical methods are very reproducible; and that QC samples improve the overall quality of pharmacokinetic concentration data and justifies their continued use.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
/
Técnicas Biossensoriais
Limite:
Humans
Idioma:
En
Revista:
Bioanalysis
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Estados Unidos