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Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
|---|---|---|---|---|---|
Searching... | 30000010251528 | QH585.5.F56 F567 2011 | Open Access Book | Book | Searching... |
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Summary
Summary
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.
Author Notes
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.
Table of Contents
| Preface | p. xi |
| Foreword | p. xiii |
| Acknowledgments | p. xv |
| Contributors | p. xvii |
| Part I Introduction | p. 1 |
| 1 Introduction to Flow Cytometry | p. 3 |
| 2 Recent Advances in Flow Cytometry: Platforms, Tools, and Challenges for Data Analysis | p. 23 |
| 3 Introduction to Biomarkers | p. 55 |
| Part II Flow Cytometry in the Drug Development Process | p. 69 |
| 4 HTS Flow Cytometry, Small-Molecule Discovery, and the NIH Molecular Libraries Initiative | p. 71 |
| 5 A Multiparameter Approach to Cell Cycle Analysis as a Standard Tool in Oncology Drug Discovery | p. 99 |
| 6 Flow Cytometry in Preclinical Toxicology/Safety Assessment | p. 123 |
| 7 Use of Flow Cytometry to Study Drug Target Inhibition in Laboratory Animals and in Early-Phase Clinical Trials | p. 151 |
| 8 CD4 T Cell Assessments in Evaluation of HIV Therapeutics | p. 169 |
| 9 Monitoring the Cellular Components of the Immune System During Clinical Trials: A Translational Medicine Approach | p. 189 |
| 10 Immunogenicity Testing Using Flow Cytometry | p. 205 |
| 11 Pharmacokinetics by Flow Cytometry: Recommendations for Development and Validation of Flow Cytometric Method for Pharmacokinetic Studies | p. 225 |
| Part III Validation and Regulatory Compliance | p. 241 |
| 12 Regulatory Compliance and Method Validation | p. 243 |
| 13 Instrument Validation for Regulated Studies | p. 267 |
| Part IV Future Directions | p. 279 |
| 14 Probability State Modeling: A New Paradigm for Cytometric Analysis | p. 281 |
| 15 Phospho Flow Cytometry: Single-Cell Signaling Networks in Next-Generation Drug Discovery and Patient Stratification | p. 303 |
| Index | p. 335 |
