Objective criteria for statistical assessments of cross validation of bioanalytical methods
Integrating Bland-Altman plots with equivalence boundaries offers a robust, statistically sound framework for cross validation in bioanalytical studies. This method enhances the quality and consistency of pharmacokinetic data, supporting more reliable clinical trial endpoints.
Authors
- Catherine L Brockus (ORCID: https://orcid.org/0009-0007-4314-6762)
- Dongyan Yan
- Marina Guadalupe Pintado Herrera (ORCID: https://orcid.org/0009-0001-5295-1268)
- Hui-Rong Qian
Institutions
- Eli Lilly (United States) (US)
Publication Details
- Journal
- Bioanalysis
- Published
- 2025-10-18
- DOI
- https://doi.org/10.1080/17576180.2025.2580280
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.00