Drug Clinical Trials and GCP

Author: Tian Shaolei
Publisher:
Publish Date: 2003-05-01
Features: This book is compiled based on the latest relevant regulations in our country and GCP guidelines from developed countries or international organizations, primarily the WHO and ICH GCP guidelines. It references domestic and international materials collected in recent years from those engaged in GCP work, combined with the author's experiences and insights from participating in and organizing GCP training. This book is primarily intended as an introductory read for doctors, nurses, pharmacists, and archival management personnel in medical institutions involved in drug clinical trials, as well as for personnel in pharmaceutical companies engaged in new drug registration or GCP monitoring. It can also serve as a reference for GCP supervision personnel in various drug regulatory departments at all levels, and as a reference book for various GCP training courses.