《临床药理学》中国医科大学PPT-Chapter 5 New drug research and clinical trials（Gao mingqi20160830） (2).pptVIP

Preclinical study of new drug Preclinical study of new drug Clinical Trial Phases Phase II trials: 20-300 patients Does treatment do what it is supposed to? How does treatment affect the body? Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II Study Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to a