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Clinical Trials Handbook

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ISBN-10: 0471213888

ISBN-13: 9780471213888

Edition: 2009 (Handbook (Instructor's))

Authors: Shayne Cox Gad, Shayne Cox Gad

List price: $187.00
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Description:

This book provides a comprehensive and thorough reference on the basics and practices of clinical trials, arguably the most important steps in proving a drug effective and safe for public use. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters include interdisciplinary topics that have to be coordinated for a successful clinical trial: data management (and adverse event reporting systems), biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas (ie, cardiology, oncology, neuroscience, etc.).
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Book details

List price: $187.00
Copyright year: 2009
Publisher: John Wiley & Sons, Limited
Publication date: 7/21/2009
Binding: Hardcover
Pages: 1248
Size: 7.25" wide x 10.25" long x 2.00" tall
Weight: 4.642
Language: English

Preface
Contributors
Introduction to Clinical Trials
Regulatory Requirements for Investigational New Drug
Preclinical Assessment of Safety in Human Subjects
Predicting Human Adverse Drug Reactions from Nonclinical Safety Studies
History of Clinical Trial Development and the Pharmaceutical Industry
Adaptive Research
Organization and Planning
Process of Data Management
Clinical Trials Data Management
Clinical Trials and the Food and Drug Administration
Phase I Clinical Trials
Phase II Clinical Trials
Designing and Conducting Phase III Studies
Phase IV: Postmarketing Trials
Phase IV and Postmarketing Clinical Trials
Regulatory Approval
New Paradigm for Analyzing Adverse Drug Events
Clinical Trials in Interventional Cardiology: Focus on XIENCE Drug-Eluting Stent
Clinical Trials Involving Oral Diseases
Dermatology Clinical Trials
Emergency Clinical Trials
Gastroenterology Lise Lotte Gluud and J�rgen Rask-Madsen
Gynecology Randomized Control Trials Khalid S. Khan, Tara Selman, and Jane Daniels
Special Population Studies (Healthy Patient Studies)
Musculoskeletal Disorders
Oncology
Pharmacological Treatment Options for Nonexudative and Exudative Age-Related Macular Degeneration
Paediatrics
Clinical Trials in Dementia
Clinical Trials in Urology
Clinical Trials on Cognitive Drugs
Bridging Studies in Pharmaceutical Safety Assessment
Brief History of Clinical Trials on Viral Vaccines
Methods of Randomization
Randomized Controlled Trials
Cross-Over Designs
Biomarkers
Biomarkers in Clinical Drug Development: Parallel Analysis of Alzheimer Disease and Multiple Sclerosis
Review Boards
Size of Clinical Trials
Blinding and Placebo
Pharmacology
Modeling and Simulation in Clinical Drug Development
Monitoring
Inference Following Sequential Clinical Trials
Statistical Methods for Analysis of Clinical Trials
Explanatory and Pragmatic Clinical Trials
Ethics of Clinical Research in Durg Trials
Ethical Issues in Clinical Research
Regulations
Future Challenges in Design and Ethics of Clinical Trials
Proof-of-Principle/Proof-of-Concept Trials in Drug Development
Index