Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 26

To obtain approval to market a new drug in the United States, Canada, the European Union, and most other countries, a series of clinical trials on patients is required. The extent of the trials depends on the drug (already approved for other uses or formulations, a new breakthrough product, expected to be very toxic, etc.), the disease or indication treated (severe diseases, such as advanced cancer versus mild allergies, diseases with no known treatments, rare diseases with few patients afflicted, etc.), the nature of the patients studied (healthy, very ill, young, old, etc.), experience in other countries where it is already sold, and other factors.