International Clinical Trials: A Guidebook to National Drug Laws is a collection of current guidelines from 34 countries into a single source that allows regulatory bodies in the pharmaceutical industry to prepare product
approval submissions and meet
international standards for performing clinical trials. It provides the information needed to perform clinical trials, from
initiation to termination and reporting, and includes forms and excerpts from existing regulations. This book is indispensable to those who must understand and comply with the standards of biomedical research on human beings as the pharmaceutical industry and regulators work to establish a universal set of requirements for