Clinical Trials Reference from C.H.I.P.S.
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Clinical Trials Handbook
edited by Shayne Cox Gad
Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials.
Chapters cover every key aspect of preparing and conducting clinical trials, including:
- Interdisciplinary topics that have to be coordinated for a successful clinical trial
- Data management (and adverse event reporting systems)
- Biostatistics, pharmacology, and toxicology
- Modeling and simulation
- Regulatory monitoring and ethics
- Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more
With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Contents
- Introduction to Clinical Trials
- Regulatory Requirements for Investigational New Drug
- Preclinical Assessment of Safety in Human Subjects
- Predicting human adverse drug reactions from non-clinical safety studies
- History of Clinical Trial Development and the Pharmaceutical Industry
- Organization and Planning
- The Process of Data Management
- Clinical Trials Data Management
- Clinical Trials and the FDA
- Phase I Clinical Trials
- Phase II Clinical Trials
- Designing and Conducting Phase III Studies
- Phase IV
- Phase IV and Post Marketing Clinical Trials
- Regulatory Approval
- A New Paradigm for Analyzing Adverse Drug Events
- Clinical Trials in Interventional Cardiology: Focus on the XIENCE Drug-Eluting Stent (Doostzadeh J, Bezenek S, Cheong W-F, Sood P, Schwartz L, Sudhir K).
- Clinical Trials Involving Oral Diseases
- Dermatology Clinical Trials
- Emergency Clinical Trials
- Gastroenterology
- Gynaecology Randomised Control Trials
- Special Population Studies (Healthy Patient Studies)
- Musculoskeletal
- Oncology
- Pharmacological Treatment Options for Non-exudative and exudative age-related macular degeneration
- Paediatrics
- Dementia
- Clinical Trials in Urology
- Clinical Trials on Cognitive Drugs
- Bridging Studies in Pharmaceutical Safety Assessment
- A Brief History of Clinical Trials on 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 a Sequential Clinical Trial
- 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 the Design and Ethics of Clinical Trials
- Proof-of-Principle/Proof-of-Concept trials in Drug Development
Index
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Clinical Trials Handbook
edited by Shayne Cox Gad
2009 • 1,225 pages • $194.00 + shipping
Texas residents please add 6.75 % sales tax
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