PREFACE ........................................................ 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
С. 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
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