Quantitative Decisions in Drug Development

• Main Authors: Chuang-Stein, Christy (Author), Kirby, Simon (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Cham : Springer International Publishing : Imprint: Springer, 2017.
• Series: Springer Series in Pharmaceutical Statistics,
• Subjects: Statistics.; Pharmaceutical technology.; Pharmacy.; Biostatistics.; Quality control.; Reliability.; Industrial safety.; Statistics for Life Sciences, Medicine, Health Sciences.; Drug Safety and Pharmacovigilance.; Pharmaceutical Sciences/Technology.; Quality Control, Reliability, Safety and Risk.

This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulato...

Table of Contents:

• 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.