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
Related Articles
- EP ID EP681071
- DOI 10.1208/s12248-013-9553-8
- Views 55
- Downloads 0
Characterization of Silvestrol Pharmacokinetics in Mice Using Liquid Chromatography–Tandem Mass Spectrometry
A sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for the quantification of the plant natural product silvestrol in mice, using ansamitocin P-3 as the inte...
Formulations for natural and peptide nucleic acids based on cationic polymeric submicron particles
This article describes the production and characterization of cationic submicron particles constituted with Eudragit RS 100, plus different cationic surfactants, such as dioctadecyl-dimethyl-ammonium bromide (DDAB18) and...
Reliability and Extension of Quantitative Prediction of CYP3A4-Mediated Drug Interactions Based on Clinical Data
The online version of this article (doi:10.1208/s12248-014-9663-y) contains supplementary material, which is available to authorized users.
Holford NHG and Sheiner LB “Understanding the Dose-Effect Relationship-Clinical Application of Pharmacokinetic-Pharmacodynamic Models”, Clin Pharmacokin 6:429–453 (1981)—The Backstory
Unbiased membrane permeability parameters for gabapentin using boundary layer approach
The present study was performed to determine the relative contribution of both passive and nonpassive transport processes in jejunal absorption of gabapentin. The oral absorption of gabapentin was studied using in situ s...