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Flow Cytometry in Drug Discovery and Development
Description:
Overview of Flow Cytometry in Drug Discovery and Development
In this book, the unique application of flow cytometry in pharmaceutical discovery and development is
presented. A basic explanation of the technology precedes a comprehensive review of specific examples of
how the technology is utilized in drug development.
Readers of this book will learn how flow cytometry's use of multiparametric, high–speed measurements and
manipulations of single cells adds valuable information and efficiencies for the discovery and development
of new, better, and more affordable pharmaceuticals. It discusses validation and regulatory compliance
issues as well as the use of cytometry in monitoring clinical diseases and evaluating therapies.
Divided into four parts, the book:
Includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on
recent advances in flow cytometry
Focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug
development process
Presents an in–depth discussion of validation considerations and regulatory compliance issues associated
with drug development
Ends with two chapters addressing important future directions in the field of flow cytometry
Written by thought–leaders from academia and industry as well as flow cytometry users from the
pharmaceutical sector, this comprehensive and straightforward text helps pharmaceutical researchers
understand the potential of flow cytometry and, in turn, allows flow cytometrists to understand the needs of
the pharmaceutical industry.
Contents:
Preface.
Foreword.
Acknowledgements.
Contributors.
Part I Introduction (Philip Marder and Virginia Litwin).
1 Introduction to Flow Cytometry (Elizabeth Raveche, Fatima Abbasi, Yao Yuan, Erica Salerno, Siddha Kasar
and Gerald Marti).
2 Recent Advances in Flow Cytometry: Platforms, Tools and the Challenges for Data Analysis (Paul J Smith,
Roy Edward, Rachel J Errington).
3 Introduction to Biomarkers (Ole Vesterqvist and Manjula Reddy).
Part II Flow Cytometry in the Drug Development Process (Virginia Litwin and Philip Marder).
4 HTS Flow Cytometry, Small Molecule Discovery, and the NIH Molecular Libraries Initiative (Larry A. Sklar
and Bruce S. Edwards).
5 A Multiparameter Approach to Cell Cycle Analysis as a Standard Tool in Oncology Drug Discovery (Carmen
Raventos–Suarez and Byron H. Long)
6 Flow Cytometry in Pre–Clinical Toxicology/Safety Assessment Environment (David McFarland and Kristi
Harkins)
7 Use of Flow Cytometry for Defining and Validating the Molecular Mechanism of Anti–cancer Drugs in
Humans (David W Hedley).
8 CD4 T cell Assessments in Evaluation of HIV Therapeutics (Thomas N. Denny, Raul Louzao, John Wong and
Brooke Walker).
9 A Translational Medicine Approach to Monitoring the Immune System during Clinical Trials (Virginia Litwin
and James Andahazy).
10 Immunogenicity Testing Using Flow Cytometry (Denise M. O'Hara and Valerie Theobald).
11 Pharmacokinetics by Flow Cytometry: Recommendations for Development and Validation of Flow
Cytometric Method for Pharmacokinetic Studies (Yuanxin Xu and Susan M Richards).
Part III Validation and Regulatory Compliance (Virginia Litwin and Philip Marder).
12 Regulatory Compliance and Method Validation (Carla Hill, Dianna Wu, John Ferbas, Virginia Litwin,
Manjula Reddy).
13 Instrument Validation for Regulated Studies (John Ferbas and Michelle Schroeder).
Part IV Future Directions (Virginia Litwin and Philip Marder).
14 Probability State Modeling: A New Paradigm for Cytometric Analysis (Bruce Bagwell).
15 Phospho Flow Cytometry: Single Cell Signaling Networks in Next Generation Drug Discovery and Patient
Stratification (Peter O. Krutzik, Sean C. Bendall, Matthew B. Hale, Jonathan M. Irish, Garry P. Nolan).
Index.
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