title: Stability: recommendation for best practices and harmonization from the Global Bioanalysis Consortium Harmonization Team.
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.
authors.affiliation: Bioanalytical Laboratory, PRA, Westerbrink 3, 9405 BJ, Assen, The Netherlands, merbelnicovande@praintl.com.
authors.forename: Nico
authors.initials: N
authors.lastname: van de Merbel
authors.forename: Natasha
authors.initials: N
authors.lastname: Savoie
authors.forename: Manish
authors.initials: M
authors.lastname: Yadav
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Ohtsu
authors.forename: Joleen
authors.initials: J
authors.lastname: White
authors.forename: Maria Francesca
authors.initials: MF
authors.lastname: Riccio
authors.forename: Kelly
authors.initials: K
authors.lastname: Dong
authors.forename: Ronald
authors.initials: R
authors.lastname: de Vries
authors.forename: Julie
authors.initials: J
authors.lastname: Diancin
mesh_terms: D004345:Drug Industry / Q000592:standards*; D004355:Drug Stability; D005615:Freezing; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis / Q000592:standards*; D012015:Reference Standards
chemical_list: D004364:Pharmaceutical Preparations