Large Molecule Run Acceptance: Recommendation for Best Practices and Harmonization from the Global Bioanalysis Consortium Harmonization Team
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 2
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.
Authors and Affiliations
Marian Kelley, Christopher Beaver, Lauren F. Stevenson, Ross Bamford, Paula Gegwich, Yamamoto Katsuhiko, Dongbei Li, Samantha Little, Arumugam Muruganandam, Daniela Stoellner, Ravi Kumar Trivedi
Keywords
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- DOI 10.1208/s12248-013-9553-8
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