Quantitative Decisions in Drug Development
This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available his...
| Main Authors: | , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2021, 2021
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| Edition: | 2nd ed. 2021 |
| Series: | Springer Series in Pharmaceutical Statistics
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| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- 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