Quantitative Decisions in Drug Development
Series: Springer Series in Pharmaceutical Statistics;
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Product details:
- Edition number Softcover reprint of the original 1st ed. 2017
- Publisher Springer International Publishing
- Date of Publication 28 July 2018
- Number of Volumes 1 pieces, Previously published in hardcover
- ISBN 9783319834344
- Binding Paperback
- See also 9783319460758
- No. of pages248 pages
- Size 235x155 mm
- Weight 454 g
- Language English
- Illustrations XV, 248 p. 27 illus., 11 illus. in color. Illustrations, black & white 0
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Long description:
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 regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm.
The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development processand the clinical trials conducted to support drug-marketing authorization.
The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.
MoreTable 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.
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