Clinical Trials Handbook
Autor: | Shayne Cox Gad |
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EAN: | 9780470466353 |
eBook Format: | |
Sprache: | Englisch |
Produktart: | eBook |
Veröffentlichungsdatum: | 17.06.2009 |
Kategorie: | |
Schlagworte: | safe; effectiveness; best practices; drug; important; clinical; data; range; disciplines; wide; given; basics; practices; reference; handbook; trials; thorough; international authors; contributions; trial; book; reader; key; chapters; every |
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Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials.
With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including:
- Interdisciplinary topics that have to be coordinated for a successful clinical trialData 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
Shayne Cox Gad, PhD, DABT, ATS, is the Principal of Gad Consulting Services. Dr. Gad has more than thirty years of experience as a toxicologist, statistical consultant, manager, and general consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is the author of thirty-nine books and numerous papers, presentations, and other publications.