International Clinical Trials

Edited by Dominique Brunier and Gerhard Nahler

Detalles del libro
Editorial: CRC Press
ISBN: 1-57491-094-9
ISBN-13: 9781574910940
Materia: Libros de Farmacologia
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 performing clinical trials.