Flow Cytometry in Drug Discovery and Development (ePub)

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

Virginia Litwin is a Principal Scientist at Covance Central
Laboratory Services. After numerous years in the
pharmaceutical/biotechnology industry, she has become a leader in
the application and validation of flow cytometric methods in drug
discovery and development. She founded the Flow Cytometry
Subcommittee of the Ligand Binding Assay Bioanalytical Focus Group
within the American Association of Pharmaceutical Scientists
(AAPS). She is an active contributor to the International Clinical
Cytometry Society (ICCS) and the International Society for
Analytical Cytology (ISAC). She received her bachelor's from the
University of California and her doctorate from the University of
Iowa.

Philip Marder was internationally distinguished for his
leadership in the application of flow cytometry in early drug
discovery and development. He was a key contributor to the
scientific community as an active member of ISAC and AAPS. After
receiving both his bachelor's and master's degrees from The Ohio
State University, he had a distinguished thirty year career at Eli
Lilly and Company.

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