Guiding Principles for the Research of Chemical Drugs and Therapeutic Biological Products

Author: Zheng Xiaoyu
Publisher:
Publish Date: 2002-05-01
Features: This book was formulated by the State Food and Drug Administration, organizing relevant experts across the country to build upon the original "Guiding Principles for New Drug Research." It primarily introduces the biostatistical guiding principles for the structural confirmation of chemical drugs and therapeutic biological products, preparation processes, quality standards, stability studies, toxicological studies, pharmacokinetic studies, bioavailability and bioequivalence studies in humans, and clinical trials. This book serves as a guiding document for new drug research and a reference book for new drug researchers. It is available for reading and reference by a broad range of new drug researchers, drug registration personnel, as well as workers in the pharmaceutical production and distribution sectors.