Clinical Research Guiding Principles for New Traditional Chinese Medicine Drugs (Trial)

Author: Zheng Xiaoyu
Publisher:
Publish Date: 2002-05-01
Features: This series is compiled by experts from across the country under the organization of the State Food and Drug Administration (SFDA), based on the relevant drug registration regulations issued by SFDA and requirements such as GCP. It systematically introduces the scientific principles and methods that should be followed in the clinical trial design of traditional Chinese medicine (TCM) new drugs, and recommends certain standardized technical reference books currently in use. The book is divided into two main parts: General Principles and Specific Cases. The General Principles elaborates on the common issues in clinical trial design methods for new drugs, while the Specific Cases cover 18 systematic sections and 79 types of conditions, introducing relevant issues for clinical research. This book is highly authoritative and serves as a reference book for researchers in research institutions, pharmaceutical companies, and clinical pharmacology bases engaged in the research and development of TCM new drugs. This book is edited by Zheng Xiaoyu. This series is compiled by experts from across the country under the organization of the State Food and Drug Administration (SFDA), based on the relevant drug registration regulations issued by SFDA and requirements such as GCP. It systematically introduces the scientific principles and methods that should be followed in the clinical trial design of traditional Chinese medicine (TCM) new drugs.