Читать книгу Clinical Pharmacology and Therapeutics - Группа авторов - Страница 123

Usually in healthy volunteers they are designed to find out how the drug affects the human body and vice versa. This will be a combination of assessing the pharmacodynamics of the drug, including detailed safety screens and the pharmacokinetics. The results of Phase I clinical studies will determine whether there is potential for the drug to move towards the next stage of development. At this stage, the drug has to be shown to be relatively safe and, where feasible, for a reasonable signal of efficacy to have been established. This is easier in some disease areas (e.g. hypertension) than others (e.g. oncology). Usually less than 100 individuals are involved.