Physician Investigator Handbook : GCP Tools and Techniques, Second Edition
Book Details
Format
Hardback or Cased Book
ISBN-10
1574911244
ISBN-13
9781574911244
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Jan 1st, 2002
Print length
482 Pages
Product Classification:
Biology, life sciences
Ksh 36,000.00
Re-Printing
0 in stock
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A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The chapters address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.
Presenting a broad research perspective, this second edition of a bestseller is a comprehensive guide for physicians conducting clinical research. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about the design, establishment, monitoring, and close-out of a trial is in this book. The authors address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.
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