Introduction to clinical trials

摘要: Purpose New drugs are first introduced into human subjects in phase I trials. The primary goal of these first studies is to assess the safety of the agent and to determine an acceptable dose for further study. Related goals include the assessment of pharmacokinetics as well as pharmacodynamics. To study pharmacokinetics is to study how the body affects the drug: How is the drug absorbed? How is the drug distributed between body compartments? How is the drug metabolized and excreted? Pharmacodynamics is the relationship between drug exposure and drug effect. Here