Quantitative Decisions in Drug Development

• Κύριοι συγγραφείς: Chuang-Stein, Christy (Συγγραφέας), Kirby, Simon (Συγγραφέας)
• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: Cham : Springer International Publishing : Imprint: Springer, 2017.
• Σειρά: Springer Series in Pharmaceutical Statistics,
• Θέματα: 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...

Πίνακας περιεχομένων:

• 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.