Quantitative Decisions in Drug Development

Clinical Testing of a New Drug.- A Frequentist Decision-making Framework.- Characteristics of a Diagnostic Test.- The Parallel Between Clinical Trials and Diagnostic Tests.- Incorporating Information from Completed Trials in Future Trial Planning.- Choosing Metrics Appropriate for Different Stages of Drug Development.- Designing Proof-of-Concept Trials with Desired Characteristics.- Designing Dose-response Studies with Desired Characteristics.- Designing Confirmatory Trials with Desired Characteristics.- Designing Phase 4 Trials.- Other Metrics That Have Been Proposed to Optimize Drug Development Decisions.- Discounting Prior Results to Account for Selection Bias.- Index.- Appendix.

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• Farmacologia
• Bioquímica
• Probabilidade e Estatística
• Sistemas de segurança e alarme contra incêndios

clinical trials;metric for decision;drug development;probability of study success;probability of product success;go/no go criteria;evidence-based decision;regulatory affairs;quality control, reliability, safety and risk