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Field name	Details
Dewey Class	519.5
Title	Quantitative Decisions in Drug Development ([EBook]) / by Christy Chuang-Stein, Simon Kirby.
Author	Chuang-Stein, Christy
Added Personal Name	Kirby, Simon author.
Other name(s)	SpringerLink (Online service)
Publication	Cham : : Springer International Publishing : : Imprint: Springer, , 2017.
Physical Details	XV, 248 p. 27 illus., 11 illus. in color. : online resource.
Series	Springer Series in Pharmaceutical Statistics 2366-8695
ISBN	9783319460765
Summary Note	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 process and 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.:
Contents note	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.
System details note	Online access to this digital book is restricted to subscription institutions through IP address (only for SISSA internal users)
Internet Site	http://dx.doi.org/10.1007/978-3-319-46076-5
Links to Related Works	Subject References: Biostatistics . Drug Safety and Pharmacovigilance . Industrial safety . Pharmaceutical Sciences/Technology . Pharmaceutical technology . Pharmacy . Quality control . Quality Control, Reliability, Safety and Risk . Reliability . Statistics . Statistics for Life Sciences, Medicine, Health Sciences . Authors: Chuang-Stein, Christy . Kirby, Simon . Corporate Authors: SpringerLink (Online service) . Series: Springer Series in Pharmaceutical Statistics . Classification: 519.5 .

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Quantitative Decisions in Drug Development

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