Ligand-binding assays : development, validation, and implementation in the drug development arena
发布日期:2010-11-12 浏览次
【内容简介】With increasing use of ligand-binding assays (LBAs) in the pharmaceutical industry, the need to critically evaluate technical and regulatory issues related to the use of these technologies has increased greatly. This book fills that void and provides a reference text covering critical aspects of the development, validation, and implementation of LBAs in the drug development field. It includes: immunochemistry and protein chemistry, method development, validation, statistics, software, regulatory issues, and applications to immunogenicity and biomarkers. This is a key resource for bioanalytical personnel, laboratory analysts, and clinical and regulatory pharmacologists.
【目次】Preface.
Contributors.
1 Ligand-Binding Assays in Drug Development: Introduction and Historical Perspective (John W.A. Findlay and Masood N. Khan).
2 Ligand-Binding Assays to Support Disposition Studies of Macromolecular Therapeutics (Marian M. Kelley, Marjorie A. Mohler, and John W.A. Findlay).
3 Development of Ligand-Binding Assays for Drug Development Support (Masood N. Khan,
4 Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics (Binodh S. DeSilva and Ronald R. Bowsher).
5 Statistical Considerations in the Validation of Ligand-Binding Assays (Bruno Boulanger, Viswanath Devanarayan, and Walthère Dewé).
6 Development and Validation of Ligand-Binding Assays for Biomarkers (Jean W. Lee, Yang Pan, Peter J. O'Brien, and Ren Xu).
7 The Use of Commercial Assay Kits for PK/PD Analysis in Drug Development (John L. Allinson and John D. Chappell).
8 Development and Validation of Immunogenicity Assays for Preclinical and Clinical Studies (Thomas H. Parish, Deborah Finco, and Viswanath Devanarayan).
9 Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis (Marie T. Rock and Stephen Keller).
10 Strategies for Successful Transfer of Ligand-Binding Assays for Successful Validation and Implementation in GXP Environment (Wolfgang Klump and Howard Hill).
11 Application of Automation in Ligand-Binding Assays (Chris Morrow).
12 Documentation and Regulatory Compliance (CT. Viswanathan and Jacqueline A. O'Shaughnessy).
13 Alternative and Emerging Methodologies in Ligand-Binding Assays (Huifen F. Wang and John W.A. Findlay).
Acknowledgment.
References.
Index.
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