Designing a drug development program can be a daunting task. Like its first edition, this text guides readers through successful design and implementation of all phases of clinical drug trials, as well as provides an overview of current procedures and issues involved in biopharmeutical development. It includes updated chapters, as well as many new chapters and features, such as highlights of critical chemical and biological considerations in drug development. Written in a practical, informative way, this textbook provides both a conceptual approach and specific information about all four phases of clinical development prior to licensure, as well as for the design of post-marketing studies.