Ligand-Binding Assays (eBook)

Masood N. Khan, PhD, received his PhD from Aligarh Muslim University, India, and did postdoctoral research at the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, in immunology and cell biology. He subsequently moved to McGill University, Montreal, Canada, and served as assistant professor in the Department of Medicine. In 1988, he established and successfully directed the Ligand-Binding Assay Bioanalytical (LBAB) Department at Phoenix International Life Sciences (currently MDS Life Sciences), Montreal. Dr. Khan is a founding member of the LBAB Focus Group at AAPS and has coauthored authoritative reviews on validation of LBA and biomarker assays. He has over 100 publications and presentations to his credit. He is currently the Chief Scientist at GLP Solutions Inc. in Rockville, Maryland. John W. A. Findlay, PhD, earned his PhD from the University of Aberdeen, Scotland, and did postdoctoral work in organic and medicinal chemistry at the University of Virginia. He has extensive experience in successful drug development with several major pharmaceutical companies, particularly in the areas of bioanalysis and drug disposition. Dr. Findlay was a participant in the first AAPS/FDA workshop on bioanalytical method validation in 1990 and in subsequent AAPS/FDA workshops on this topic, as well as a coauthor of a guiding review article in this field published in 2000. Dr. Findlay has coauthored more than 140 original papers, reviews, book chapters, patents, and abstracts. He is currently a Senior Director in Clinical Pharmacology at Gilead Sciences in Durham, North Carolina.

Preface.

Chapter 1 Introduction and Historical Perspective (John W. A. Findlay and Masood N. Khan).

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

Chapter 3 Development of Ligand-Binding Assays for Drug Development Support (Masood Khan, Proveen Dass, John Leete, Michele Gunsior, Richard Schuman, and Chanchal Sadhu).

Chapter 4 Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Biotherapeutics (Binodh DeSilva and Ronald R. Bowsher).

Chapter 5 Statistical Considerations in the Validation of Ligand-Binding Assays (Bruno Boulanger, Viswanath Devanarayan and Walthere & Dewe).

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

Chapter 7 The Use of Commercial Assay Kits for PK/PD Analysis in Drug Development (John L. Allinson and John D. Chappel).

Chapter 8 Development and Validation of Immunogenicity Assays for Pre-Clinical and Clinical Studies (Thomas Parish, Deborah Finco-Kent and Viswanath Devanarayan).

Chapter 9 Macromolecular Reference Standards for Biotherapeutic Pharmacokinetic Analysis (Marie T. Rock and Stephen Keller).

Chapter 10 Strategies for Transfer of Ligand-Binding Assays for Successful Validation and Implementation in GXP Environments (Wolfgang Klump and Howard Hill).

Chapter 11 Application of Automation in Ligand-Binding Assays (Chris Morrow).

Chapter 12 Documentation and Regulatory Compliance (Jacqueline A. O'Shaughnessy and C. T. Viswanathan).

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

"Ligand-Binding Assays, written by recognized and respected
industry experts, covers a wide range of topics that provide
valuable information to someone who is new to the field." (News
& Analysis, 2011)

"Ligand-Binding Assays, edited by Masood Kahn and John
Findlay offers a comprehensive, in depth description of all aspects
of the subject. The editors are directly involved in the
ligand-binding assay field and individual chapters are written by
experts with a thorough understanding of the specific topics. The
book is easy to read, clear and well illustrated. The emphasis is
on biologicals rather than small molecules and this reflects the
current application of many of the procedures covered. There is a
good overview of assay validation, and this book is highly
recommended for those with an interest in the topic."

--Robin Thorpe, PhD FRCPath, National Institute for
Biological Standards and Control

"This book is a collection of valuable articles describing these
assays in some detail, both from a historical perspective ..., but
also regarding the new developments in the field, such as new
technologies to support drug development ... and pharmacokinetic
research." (ChemMedChem, July 2010)

"Ligand-Binding Assays, edited by Masood Kahn and John
Findlay offers a comprehensive, in depth description of all aspects
of the subject. The editors are directly involved in the
ligand-binding assay field and individual chapters are written by
experts with a thorough understanding of the specific topics. The
book is easy to read, clear and well illustrated. The emphasis is
on biologicals rather than small molecules and this reflects the
current application of many of the procedures covered. There is a
good overview of assay validation, and this book is highly
recommended for those with an interest in the topic."

--Robin Thorpe, PhD FRCPath, National Institute for
Biological Standards and Control

"This book is a collection of valuable articles describing these
assays in some detail, both from a historical perspective ..., but
also regarding the new developments in the field, such as new
technologies to support drug development ... and pharmacokinetic
research." (ChemMedChem, July 2010)