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

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Medley

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condemn

作呕

wall-stress

The Parallel Between Clinical Trials and Diagnostic Tests,fference between statistical power and the probability of a positive trial. This last point becomes more important as a new drug moves through the various development stages as will be illustrated in Chap. 9.

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Incorporating Information from Completed Trials in Future Trial Planning,ities under some definitions of success. We can use simulations to estimate these probabilities when close-form expressions do not exist. With the use of prior distributions for the parameters of interest, we show how to assess the positive and negative predictive values of a design with its companion decision rule.

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Designing Phase 4 Trials,o consider a trial comparing a drug against a comparator using information obtained from the network meta-analysis. We also discuss how prior distributions for treatment effects may be obtained by other means such as PK/PD modeling.

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