Designing a drug development program or key study can be a daunting task due to growing limitations on time and resources in industry and in academia. Scientific advances and increasing competition in the drug development arena demand a quick, easy-to-use source of data. The Handbook of Phase I/II Clinical Drug Trials is that source. It is an indispensable guide, readily providing the information needed to make crucial decisions regarding drug therapies. This book makes it easy to plan cost-effective, early drug development programs. The first four sections of the text deal with the preliminaries to studying drugs in humans, as well as considerations common to early drug trials in human subjects. Part II considers organization and decision making factors. Ethical and legal considerations are discussed in the next section. Subsequent chapters deal with specific therapeutic areas and indications. Areas of growing importance, such as studying in vitro metabolism in human hepatocytes and genetic engineering are highlighted as well. The Handbook of Phase I/II Clinical Drug Trials is your complete guide to successful early drug development.