Bioanalytical LC-MS/MS validation of therapeutic drug monitoring assays in oncology.
Biomed Chromatogr
; 34(1): e4623, 2020 Jan.
Article
em En
| MEDLINE
| ID: mdl-31215049
ABSTRACT
Therapeutic drug monitoring (TDM) has shown to benefit patients treated with drugs of many drug classes, among which is oncology. With an increasing demand for drug monitoring, new assays have to be developed and validated. Guidelines for bioanalytical validation issued by the European Medicines Agency and US Food and Drug Administration are applicable for clinical trials and toxicokinetic studies and demand fully validated bioanalytical methods to yield reliable results. However, for TDM assays a limited validation approach is suggested based on the intended use of these methods. This review presents an overview of publications that describe method validation of assays specifically designed for TDM. In addition to evaluating current practice, we provide recommendations that could serve as a guide for future validations of TDM assays.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cromatografia Líquida
/
Monitoramento de Medicamentos
/
Espectrometria de Massas em Tandem
/
Antineoplásicos
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Biomed Chromatogr
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Holanda