Bioanalytical method validation for macromolecules in support of pharmacokinetic studies

The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report o...

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Bibliographic Details
Published in:Pharmaceutical research 2005-09, Vol.22 (9), p.1425-1431
Main Authors: Smolec, JoMarie, DeSilva, Binodh, Smith, Wendell, Weiner, Russell, Kelly, Marian, Lee, Ben, Khan, Masood, Tacey, Richard, Hill, Howard, Celniker, Abbie, Shah, Vinod, Bowsher, Ronald, Mire-Sluis, Anthony, Findlay, John W A, Saltarelli, Mary, Quarmby, Valerie, Lansky, David, Dillard, Robert, Ullmann, Martin, Keller, Stephen, Karnes, H Thomas
Format: Article
Language:English
Subjects:
Calibration
Chemistry Techniques, Analytical
Immunoassay
Laboratories
Ligands
Methods
Pharmaceuticals
Pharmacokinetics
R&D
Reference Standards
Reproducibility of Results
Research & development
Sensitivity and Specificity
Workshops
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Summary:The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-005-5917-9