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