Titlebook: Quantitative Decisions in Drug Development; Christy Chuang-Stein,Simon Kirby Book 2021Latest edition The Editor(s) (if applicable) and The

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Additional Topics,ata. We also extend the concept of study success to regulatory and technical success. We wrap up the book by sharing the story of dabigatran where a higher dose of the drug, and not a lower dose, was approved based on an overall benefit–risk assessment.

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A Frequentist Decision-Making Framework,velopment, the two actions correspond to progressing or not progressing a drug for further development. These two actions are fundamental to decision making in drug development. The Frequentist approach to statistical inference involves examining probability via its long-run frequency interpretation

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Incorporating Information from Completed Trials and Other Sources in Future Trial Planning,consider the Bayesian approach to incorporate existing information into future trial planning. Under the Bayesian approach, prior distributions are used to describe the accumulated knowledge about unknown parameters such as responses to controls in previous trials and estimates pertaining to treatme

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