Description
Book SynopsisThe unique application of flow cytometry in drug discovery and development is the focus of this book. It covers flow cytometry and biomarkers, information on recent advances in flow cytometry, and presents the unique challenges and added benefits associated with the use of flow cytometry in the drug development process.
Trade Review"Flow Cytometry in Drug Discovery and Development is a monograph which comprehensively addresses the technical aspects of flow cytometry applied to drug development. Readers will learn how the unique benefits of this powerful analytical technique can be realized in the drug development process." (Analytical and Bioanalytical Chemistry, 29 July 2012)
"This book covers the unique application of flow cytometry in drug discovery and development." (Smart Grid, 15 February 2011)
Table of ContentsPreface xi
Foreword xiii
Acknowledgments xv
Contributors xvii
Part I Introduction 1
Philip Marder and Virginia Litwin
1 Introduction to Flow Cytometry 3
Elizabeth Raveche, Fatima Abbasi, Yao Yuan, Erica Salerno, Siddha Kasar, and Gerald E. Marti
2 Recent Advances in Flow Cytometry: Platforms, Tools, and Challenges for Data Analysis 23
Paul J. Smith, Roy Edward, and Rachel J. Errington
3 Introduction to Biomarkers 55
Ole Vesterqvist and Manjula P. Reddy
Part II Flow Cytometry In The Drug Development Process 69
Virginia Litwin and Philip Marder
4 HTS Flow Cytometry, Small-Molecule Discovery, and the NIH Molecular Libraries Initiative 71
Larry A. Sklar and Bruce S. Edwards
5 A Multiparameter Approach to Cell Cycle Analysis as a Standard Tool in Oncology Drug Discovery 99
Carmen Raventos-Suarez and Byron H. Long
6 Flow Cytometry in Preclinical Toxicology/Safety Assessment 123
David McFarland and Kristi R. Harkins
7 Use of Flow Cytometry to Study Drug Target Inhibition in Laboratory Animals and in Early-Phase Clinical Trials 151
David W. Hedley
8 CD4 T Cell Assessments in Evaluation of HIV Therapeutics 169
Thomas N. Denny, Raul Louzao, John Wong, and Brooke Walker
9 Monitoring the Cellular Components of the Immune System During Clinical Trials: A Translational Medicine Approach 189
Virginia Litwin and James Andahazy
10 Immunogenicity Testing Using Flow Cytometry 205
Denise M. O.Hara and Valerie Theobald
11 Pharmacokinetics by Flow Cytometry: Recommendations for Development and Validation of Flow Cytometric Method for Pharmacokinetic Studies 225
Yuanxin Xu and Susan M. Richards
Part III Validation And Regulatory Compliance 241
Virginia Litwin and Philip Marder
12 Regulatory Compliance and Method Validation 243
Carla G. Hill, Dianna Y. Wu, John Ferbas, Virginia Litwin, and Manjula P. Reddy
13 Instrument Validation for Regulated Studies 267
John Ferbas and Michelle J. Schroeder
Part IV Future Directions 279
Virginia Litwin and Philip Marder
14 Probability State Modeling: A New Paradigm for Cytometric Analysis 281
C. Bruce Bagwell
15 Phospho Flow Cytometry: Single-Cell Signaling Networks in Next-Generation Drug Discovery and Patient Stratification 303
Peter O. Krutzik, Sean C. Bendall, Matthew B. Hale, Jonathan M. Irish, and Garry P. Nolan
Index 335
