Ligand-binding assays: development, validation, and implementation in the drug development arena (Hoboken, 2010). - ОГЛАВЛЕНИЕ / CONTENTS
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ОбложкаLigand-binding assays: development, validation, and implementation in the drug development arena / ed. by M.N.Khan, J.W.A.Findlay. - Hoboken: Wiley, 2010. - xvi, 403 p.: ill. - Incl. bibl. ref. - Ind.: p.381-401. - ISBN 978-0-470-04138-3
 

Оглавление / Contents
 
Preface ........................................................ xi
Contributors ................................................... xv

1  Ligand-Binding Assays in Drug Development: Introduction
   and Historical Perspective ................................... 1
   John W.A. Findlay and Masood N. Khan

2  Ligand-Binding Assays to Support Disposition Studies
   of Macromolecular Therapeutics .............................. 15
   Marian M. Kelley, Marjorie A. Mohler, and John W.A. Findlay

3  Development of Ligand-Binding Assays for Drug Development
   Support ..................................................... 39
   Masood N. Khan, Proveen D. Dass, John H. Leete, Richard
   F. Schuman, Michele Gunsior, and Chanchal Sadhu

4  Validation of Ligand-Binding Assays to Support
   Pharmacokinetic Assessments of Biotherapeutics .............. 81
   Binodh S. DeSilva and Ronald R. Bowsher

5  Statistical Considerations in the Validation of Ligand-
   Binding Assays ............................................. 111
   Bruno Boulanger, Viswanath Devanarayan, and Walthère Dewé

6  Development and Validation of Ligand-Binding Assays
   for Biomarkers ............................................. 129
   Jean W. Lee, Yang Pan, Peter J. О'Brien, and Ren Xu

7  The Use of Commercial Assay Kits for PK/PD Analysis in
   Drug Development ........................................... 163
   John L. Allinson and John D. Chappell

8  Development and Validation of Immunogenicity Assays for
   Preclinical and Clinical Studies ........................... 193
   Thomas H. Parish, Deborah Finco, and Viswanath Devanarayan

9  Macromolecular Reference Standards for Biotherapeutic
   Pharmacokinetic Analysis ................................... 239
   Marie T. Rock and Stephen Keller

10 Strategies for Successful Transfer of Ligand-Binding
   Assays for Successful Validation and Implementation in GXP
   Environment ................................................ 265
   Wolfgang Klump and Howard Hill

11 Application of Automation in Ligand-Binding Assays ......... 287
   Chris Morrow

12 Documentation and Regulatory Compliance .................... 327
   C.T. Viswanathan and Jacqueline A. O'Shaughnessy

13 Alternative and Emerging Methodologies in Ligand-Binding
   Assays ..................................................... 343
   Huifen F. Wang and John W.A. Findlay

Index ......................................................... 381


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