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yuan y model assisted bayesian designs 2023

Type:: E-books
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Uploaded On:: Oct. 12, 2022, 9:53 a.m.
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Textbook in PDF format Bayesian adaptive designs provide a critical approach to improve the efficiency and success of drug development that has been embraced by the US Food and Drug Administration (FDA). This is particularly important for early phase trials as they form the basis for the development and success of subsequent phase II and III trials.The objective of this book is to describe the state-of-the-art model-assisted designs to facilitate and accelerate the use of novel adaptive designs for early phase clinical trials. Model-assisted designs possess avant-garde features where superiority meets simplicity. Model-assisted designs enjoy exceptional performance comparable to more complicated model-based adaptive designs, yet their decision rules often can be pre-tabulated and included in the protocol—making implementation as simple as conventional algorithm-based designs. An example is the Bayesian optimal interval (BOIN) design, the first dose-finding design to receive the fit-for-purpose designation from the FDA. This designation underscores the regulatory agency's support of the use of the novel adaptive design to improve drug development. Bayesian Statistics and Adaptive Designs Algorithm-Based and Model-Based Dose Finding Designs Model-Assisted Dose Finding Designs Drug-Combination Trials Late-Onset Toxicity Incorporating Historical Data Multiple Toxicity Grades Finding Optimal Biological Dose

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Yuan Y. Model-Assisted Bayesian Designs...2023.pdf 8.4 MB

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yuan y model assisted bayesian designs 2023

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