Ligand-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  Место хранения:   056 | Институт химической биологии и фундаментальной медицины CO РАН | Новосибирск| Библиотека

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