Newly updated and expanded for 2008, this industry-leading Good Clinical Practice (GCP) training and reference guide answers approximately 500 of the most common and difficult questions regarding the day-to-day interpretation and implementation of GCP requirements for drugs and biologics.

While maintaining a U.S./FDA focus, the guide has been expanded to provide even more information on not only U.S. GCP, but international GCP issues in, for example, the European Union, Canada, India, Latin America, Russia, and China. This is the guide for educating professionals on the many emerging complexities of GCP standards.

By Mark P. Mathieu, ed.

ISBN: 978-1882615865; 2008; 600 pages; spiral bound