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E-grāmata: Flow Cytometry in Drug Discovery and Development

Edited by (Ohio State University), Edited by (University of California; University of Iowa)
  • Formāts: PDF+DRM
  • Izdošanas datums: 12-Oct-2010
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9780470910078
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Flow Cytometry in Drug Discovery and DevelopmentPalielināt
  • Formāts: PDF+DRM
  • Izdošanas datums: 12-Oct-2010
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9780470910078
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"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"--Provided by publisher.

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.

Recenzijas

"Flow Cytometry in Drug Discovery and Development is a monograph which comprehensively addresses the technical aspects of flow cytometry applied to drug development.  Readers will learn how the unique benefits of this powerful analytical technique can be realized in the drug development process."  (Analytical and Bioanalytical Chemistry, 29 July 2012)

"This book covers the unique application of flow cytometry in drug discovery and development." (Smart Grid, 15 February 2011)

Preface xi
Foreword xiii
Acknowledgments xv
Contributors xvii
PART I INTRODUCTION
1(68)
Philip Marder
Virginia Litwin
1 Introduction to Flow Cytometry
3(20)
Elizabeth Raveche
Fatima Abbasi
Yao Yuan
Erica Salerno
Siddha Kasar
Gerald E. Marti
2 Recent Advances in Flow Cytometry: Platforms, Tools, and Challenges for Data Analysis
23(32)
Paul J. Smith
Roy Edward
Rachel J. Errington
3 Introduction to Biomarkers
55(14)
Ole Vesterqvist
Manjula P. Reddy
PART II FLOW CYTOMETRY IN THE DRUG DEVELOPMENT PROCESS
69(172)
Virginia Litwin
Philip Marder
4 HTS Flow Cytometry, Small-Molecule Discovery, and the NIH Molecular Libraries Initiative
71(28)
Larry A. Sklar
Bruce S. Edwards
5 A Multiparameter Approach to Cell Cycle Analysis as a Standard Tool in Oncology Drug Discovery
99(24)
Carmen Raventos-Suarez
Byron H. Long
6 Flow Cytometry in Preclinical Toxicology/Safety Assessment
123(28)
David McFarland
Kristi R. Harkins
7 Use of Flow Cytometry to Study Drug Target Inhibition in Laboratory Animals and in Early-Phase Clinical Trials
151(18)
David W. Hedley
8 CD4 T Cell Assessments in Evaluation of HIV Therapeutics
169(20)
Thomas N. Denny
Raul Louzao
John Wong
Brooke Walker
9 Monitoring the Cellular Components of the Immune System During Clinical Trials: A Translational Medicine Approach
189(16)
Virginia Litwin
James Andahazy
10 Immunogenicity Testing Using Flow Cytometry
205(20)
Denise M. O'Hara
Valerie Theobald
11 Pharmacokinetics by Flow Cytometry: Recommendations for Development and Validation of Flow Cytometric Method for Pharmacokinetic Studies
225(16)
Yuanxin Xu
Susan M. Richards
PART III VALIDATION AND REGULATORY COMPLIANCE
241(38)
Virginia Litwin
Philip Marder
12 Regulatory Compliance and Method Validation
243(24)
Carlo G. Hill
Dianna Y. Wu
John Ferbas
Virginia Litwin
Manjula P. Reddy
13 Instrument Validation for Regulated Studies
267(12)
John Ferbas
Michelle J. Schroeder
PART IV FUTURE DIRECTIONS
279(56)
Virginia Litwin
Philip Marder
14 Probability State Modeling: A New Paradigm for Cytometric Analysis
281(22)
C. Bruce Bagwell
15 Phospho Flow Cytometry: Single-Cell Signaling Networks in Next-Generation Drug Discovery and Patient Stratification
303(32)
Peter O. Krutzik
Sean C. Bendall
Matthew B. Hale
Jonathan M. Irish
Garry P. Nolan
Index 335
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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