Emerging Topics in Dose-Finding and Beyond
摘要
Finding the right dose or doses is one of the most important objectives in new drug development. In practice, dose-finding is a very difficult challenge in every phase of clinical development for new drugs. The first book on “Dose-Finding in Drug Development”, published in 2006, is considered the leading reference in the environs of dose-response for clinical trials. Since this book was published, many advancements have occurred. As a vehicle to promote state-of-the-science research and development in dose-finding and beyond in drug development, a conference “Dose-Finding and Other Topics in Drug Development” was held in June 2023 at the University of Connecticut. As a result, its organizing committee co-edited this up-to-date volume based on and inspired by the conference. The first chapter in the book coalesces the 2006 book and the new book from the 2023 conference. In doing so, Sect. 1 revisits the basic principles of dose-finding from the 2006 book. Section 2 discusses and compares the topic of dose-finding in oncology versus non-oncologic diseases in drug development; as a result, this section also introduces a paradigm shift in oncology drug development. Section 3 discusses new advancements made since 2006. Section 4 includes a discussion and conclusions.