Flow Cytometry in Drug Discovery and Development

This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.Content: Chapter 1 Introduction to Flow Cytometry (pages 3–21): Elizabeth Raveche, Fatima Abbasi, Yao Yuan, Erica Salerno, Siddha Kasar and Gerald E. MartiChapter 2 Recent Advances in Flow Cytometry: Platforms, Tools, and Challenges for Data Analysis (pages 23–54): Paul J. Smith, Roy Edward and Rachel J. ErringtonChapter 3 Introduction to Biomarkers (pages 55–68): Ole Vesterqvist and Manjula P. ReddyChapter 4 HTS Flow Cytometry, Small?Molecule Discovery, and the NIH Molecular Libraries Initiative (pages 71–97): Larry A. Sklar and Bruce S. EdwardsChapter 5 A Multiparameter Approach to Cell Cycle Analysis as a Standard Tool in Oncology Drug Discovery (pages 99–122): Carmen Raventos?Suarez and Byron H. LongChapter 6 Flow Cytometry in Preclinical Toxicology/Safety Assessment (pages 123–150): David McFarland and Kristi R. HarkinsChapter 7 Use of Flow Cytometry to Study Drug Target Inhibition in Laboratory Animals and in Early?Phase Clinical Trials (pages 151–168): David W. HedleyChapter 8 CD4 T Cell Assessments in Evaluation of HIV Therapeutics (pages 169–187): Thomas N. Denny, Raul Louzao, John Wong and Brooke WalkerChapter 9 Monitoring the Cellular Components of the Immune System During Clinical Trials: A Translational Medicine Approach (pages 189–203): Virginia Litwin and James AndahazyChapter 10 Immunogenicity Testing Using Flow Cytometry (pages 205–223): Denise M. O'Hara and Valerie TheobaldChapter 11 Pharmacokinetics by Flow Cytometry: Recommendations for Development and Validation of Flow Cytometric Method for Pharmacokinetic Studies (pages 225–240): Yuanxin Xu and Susan M. RichardsChapter 12 Regulatory Compliance and Method Validation (pages 243–266): Carla G. Hill, Dianna Y. Wu, John Ferbas, Virginia Litwin and Manjula P. ReddyChapter 13 Instrument Validation for Regulated Studies (pages 267–277): John Ferbas and Michelle J. SchroederChapter 14 Probability State Modeling: A New Paradigm for Cytometric Analysis (pages 281–302): C. Bruce BagwellChapter 15 Phospho Flow Cytometry: Single?Cell Signaling Networks in Next?Generation Drug Discovery and Patient Stratification (pages 303–334): Peter O. Krutzik, Sean C. Bendall, Matthew B. Hale, Jonathan M. Irish and Garry P. Nolan