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Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development.
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For health economic modellers and researchers, in industry, government, or academia, who wish to perform VOI analysis in health economic evaluations.... Læs mere
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Single-arm phase II trial is a key component for developing advanced cancer drug and treatment to target therapy and immunotherapy in which time-to-event... Læs mere
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This book presents the data mining techniques with focus on likelihood ratio test (LRT) based methods for signal... Læs mere
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This handbook is intended to serve as a reference text on statistical methods for randomized controlled trials. It can be used as a... Læs mere
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Methodologies in Biosimilar Product Development covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product.
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Advances in technology and data infrastructure call for innovations in clinical trial design. This book will be an important showcase of the potential for... Læs mere
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This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge... Læs mere
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An Introduction to clinical trials is a concise step-by-step guide to the principles and practices of clinical trials for those studying clinical trials or new to working on one.
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