Quantitative Decisions in Drug Development

Quantitative Decisions in Drug Development

Kirby, Simon; Chuang-Stein, Christy

Springer Nature Switzerland AG

09/2021

342

Dura

Inglês

9783030797300

15 a 20 dias

711

Descrição não disponível.

Chapter 1 - Clinical Testing of a New Drug.- Chapter 2 - A Frequentist Decision-making Framework.- Chapter 3 - Characteristics of a Diagnostic Test.- Chapter 4 - The Parallel Between Clinical Trials and Diagnostic Tests.- Chapter 5 - Incorporating Information from Completed Trials in Future Trial Planning.- Chapter 6 - Choosing Metrics Appropriate for Different Stages of Drug Development.- Chapter 7 - Designing Proof-of-Concept Trials with Desired Characteristics.- Chapter 8 - Designing Dose-response Studies with Desired Characteristics.- Chapter 9 - Designing Confirmatory Trials with Desired Characteristics.- Chapter 10 - Designing Phase 4 Trials.- Chapter 11 - Other Metrics That Have Been Proposed to Optimize Drug Development Decisions.- Chapter 12 - Discounting Prior Results to Account for Selection Bias.- Chapter 13 - Adaptive Designs.- Chapter 14 - Additional Topics.

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clinical trials;metric for decision;drug development;probability of study success;probability of product success;go/no go criteria;evidence-based decision;regulatory affairs