Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team

Nico van de Merbel, Natasha Savoie, Manish Yadav, Yoshiaki Ohtsu, Joleen White, Maria Francesca Riccio, Kelly Dong, Ronald de Vries, Julie Diancin

OnderzoeksoutputAcademicpeer review

63 Citaten (Scopus)

Samenvatting

This paper provides a comprehensive overview of stability-related aspects of quantitative bioanalysis and recommends science-based best practices, covering small and large molecules as well as chromatographic and ligand-binding assays. It addresses general aspects, such as the use of reference values, transferability and treatment of failing stability results, and also focuses on specific types of stability assessment: bench-top, freeze/thaw and long-term frozen stability, stock stability, extract stability, stability in whole blood, tissue and urine, and stability of endogenous analytes, in special matrix types and in incurred samples.

Originele taal-2English
Pagina's (van-tot)392-399
Aantal pagina's8
TijdschriftAaps journal
Volume16
Nummer van het tijdschrift3
DOI's
StatusPublished - mei-2014
Extern gepubliceerdJa

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