Ligand-binding assays : development, validation, and implementation in the drug development arena /

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Bibliographic Details
Other Authors: Khan, Masood N., Findlay, John W. A.
Format: Book
Language:English
Published: Hoboken, N.J. : Wiley, 2010
Subjects:

MARC

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245 0 0 |a Ligand-binding assays :  |b development, validation, and implementation in the drug development arena /  |c edited by Masood N. Khan, John W.A. Findlay. 
264 1 |a Hoboken, N.J. :  |b Wiley,  |c [2010] 
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300 |a xvi, 403 pages :  |b illustrations ;  |c 25 cm 
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504 |a Includes bibliographical references and index. 
505 0 |a Introduction and historical perspective / John W.A. Findlay and Masood N. Khan -- Ligand-binding assays to support disposition studies of macromolecular therapeutics / Marian M. Kelley, Marjorie A. Mohler, and John W.A. Findlay -- Development of ligand-binding assays for drug development support / Masood Khan ... [et al.] -- Validation of ligand-binding assays to support pharmacokinetic assessments of biotherapeutics / Binodh Desilva and Ronald R. Bowsher -- Statistical considerations in the validation of ligand-binding assays / Bruno Boulanger, Viswanath Devanarayan, and Walthere Dewe -- Development and validation of ligand-binding assays for biomarkers / Jean W. Lee ... [et al.]. 
505 0 |a The use of commercial assay kits for PK/PD analysis in drug development / John L. Allinson and John D. Chappell -- Development and validation of immunogenicity assays for preclinical and clinical studies / Thomas H. Parish, Deborah Finco, and Viswanath Devanarayan -- Macromolecular reference standards for biotherapeutic pharmacokinetic analysis / Marie T. Rock and Stephen Keller -- Strategies for successful transfer of ligand-binding assays for successful validation and implementation in GXP environment / Wolfgang Klump and Howard Hill -- Application of automation in ligand-binding assays / Chris Morrow -- Documentation and regulatory compliance / C.T. Viswanathan and Jacqueline A. O'Shaughnessy -- Alternative and emerging methodologies in ligand-binding assays / Huifen F. Wang and John W.A. Findlay. 
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