Titlebook: Quantitative Decisions in Drug Development; Christy Chuang-Stein,Simon Kirby Book 20171st edition Springer International Publishing AG 201

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Clinical Testing of a New Drug,development plan and new regulatory approval pathways. We offer some examples of recent advancements in clinical trial designs and conclude the chapter with a short summary of the salient points covered in the chapter.

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A Frequentist Decision-Making Framework,ons under the Frequentist approach are calibrated by how they would perform when they are used repeatedly. In the context of drug development, 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.

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Characteristics of a Diagnostic Test,ew the metrics commonly used to characterize the performance of a diagnostic test. We then discuss what it means when a diagnostic test returns a positive or a negative result. We illustrate the discussions with the use of several decision rules.

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Book 20171st editionical industry who have a basic understanding of the drug-development processand the clinical trials conducted to support drug-marketing authorization.. .The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow stat

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