Stability: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 3
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 and Affiliations
Nico van de Merbel, Natasha Savoie, Manish Yadav, Yoshiaki Ohtsu, Joleen White, Maria Francesca Riccio, Kelly Dong, Ronald de Vries, Julie Diancin
Keywords
Related Articles
- EP ID EP681689
- DOI 10.1208/s12248-014-9573-z
- Views 66
- Downloads 0
Influence of Copolymer Composition on In Vitro and In Vivo Performance of Celecoxib-PVP/VA Amorphous Solid Dispersions
Previous studies suggested that an amorphous solid dispersion with a copolymer consisting of both hydrophobic and hydrophilic monomers could improve the dissolution profile of a poorly water-soluble drug compared to the...
Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies
The online version of this article (doi:10.1208/s12248-014-9661-0) contains supplementary material, which is available to authorized users.
Assessment of In Vivo Clinical Product Performance of a Weak Basic Drug by Integration of In Vitro Dissolution Tests and Physiologically Based Absorption Modeling
Effective integration of in vitro tests and absorption modeling can greatly improve our capability in understanding, comparing, and predicting in vivo performances of clinical drug products. In this case, we used a propr...
A random sampling approach for robust estimation of tissue-to-plasma ratio from extremely sparse data
This study was performed to develop a new nonparametric approach for the estimation of robust tissue-to-plasma ratio from extremely sparsely sampled paired data (ie, one sample each from plasma and tissue per subject). T...
Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation
The continued globalization of pharmaceutics has increased the demand for companies to know and understand the regulations that exist across the globe. One hurdle facing pharmaceutical and biotechnology companies develop...