Clinical trials of drugs

Author: (USA) Monkhauser / (USA) Rhodes / Zhao Jian / Yu Tianji
Publisher:
Publish Date: 2004-10-01
Features: New drug research and development is a vast and complex systematic project, requiring significant investment and time, involving multiple disciplines and professions. According to the workflow, it can be divided into two stages: laboratory trials and clinical trials. Laboratory trials, also known as preclinical or non-clinical trials, involve animal subjects. Pharmacological and toxicological tests are conducted to evaluate the efficacy and safety of new drugs on animals, primarily carried out by pharmacologists and toxicologists. Clinical trials involve human subjects, observing the efficacy and side effects of new drugs on diseases, while also comparing them with already marketed similar drugs as reference drugs. New drug clinical trials are divided into four phases: Phase I, Phase II, Phase III, and Phase IV. Since new drug clinical trials involve human subjects, they must comply with the ethical principles of the Helsinki Declaration and the International Ethical Guidelines for Biomedical Research on Human Subjects, issued by the International Committee of Medical Ethics, and adhere to China's relevant laws and regulations on drug management. After applying for new drug registration and obtaining an approval certificate, the drug can be put into market production. This book is a specialized work on drug clinical trials and is the 87th volume of the Pharmaceutical and Formulation Science Series. The contributors include university teachers from the USA, UK, France, Japan, Australia, and other countries, researchers from pharmaceutical groups and scientific research departments, healthcare administrative officials, and engineering technicians from pharmaceutical factories. The book is divided into 17 chapters, covering general principles of clinical trials. It can serve as a reference for personnel in teaching, R&D, production, and management departments.