Phase 2 is the most critical stage in the entire clinical development process of a new drug because results from this phase are used to make go or no-go decisions for phase 3, and phase 3 consumes the greatest resources in new drug R&D. This is especially true in the development of drugs to treat chronic diseases. In this article we discuss the background, objectives, and risks in phase 2 development. One of the key challenges is how to design the first dose-ranging clinical trial. A practical application is suggested and two examples are discussed.
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