Theory of Drug Development (2013) Pdf Free Download

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This book will provide the reader with a rationale for the practice of drug development, both from the perspective of a drug company as well as from the perspective of a regulatory agency. In many situations, the theory presented herein should facilitate an understanding of the current practice of drug development. However, in some cases the theory presented here may not exactly coincide with current practice and indeed may point to other ways of conducting or evaluating clinical trials. In either case, the quantitative foundation provided here will enable us to more systematically address issues that arise in drug development. Examples of such issues that are addressed in this book include the following: What is the impact of adaptive designs on the quality of drugs that receive marketing approval? How

can we design a Phase 3 pivotal study that permits data-driven adjustment of the treatment effect estimate? When do we have enough information to know that a drug improves survival time for the whole patient population, not just the fraction of the patient experience represented by the amount of follow-up time in the study? We can start to approach problems like this in a systematic way once we have quantified many of the ideas underlying drug development, as has been done in this book.

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