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

AAPS J. 2014 May;16(3):392-9. doi: 10.1208/s12248-014-9573-z. Epub 2014 Feb 19.

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.

Publication types

  • Review

MeSH terms

  • Drug Industry / standards*
  • Drug Stability*
  • Freezing
  • Humans
  • Pharmaceutical Preparations / analysis
  • Pharmaceutical Preparations / standards*
  • Reference Standards

Substances

  • Pharmaceutical Preparations