Clinical Trials Handbook / Pharmaceutical Development (PDF)

Best practices for conducting effective and safe clinical
trials

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

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.