Abstract
The L1 Global Harmonization Team provides recommendations specifically for run acceptance of ligand binding methods used in bioanalysis of macromolecules in support of pharmacokinetics. The team focused on standard curve calibrators and quality controls for use in both pre-study validation and in-study sample analysis, including their preparation and acceptance criteria. The team also considered standard curve editing and the concept of total error.
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Acknowledgments
The team would like to thank Drs. Ronald Bowsher and Binodh DeSilva for their contributions to the discussions on run acceptance.
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Guest Editors: Binodh DeSilva and Philip Timmerman
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Kelley, M., Beaver, C., Stevenson, L.F. et al. Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team. AAPS J 16, 221–225 (2014). https://doi.org/10.1208/s12248-013-9553-8
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DOI: https://doi.org/10.1208/s12248-013-9553-8