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101 0 $aeng
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200 10$aQuantitative Decisions in Drug Development$b[electronic resource] /$fby Christy Chuang-Stein, Simon Kirby
205   $a1st ed. 2017.
210  1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2017.
215   $a1 online resource (XV, 248 p. 27 illus., 11 illus. in color.) 
225 1 $aSpringer Series in Pharmaceutical Statistics,$x2366-8695
311   $a3-319-46075-7 
320   $aIncludes bibliographical references at the end of each chapters and index.
327   $aClinical 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.
330   $aThis book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. The latter include selecting appropriate metrics to formulate decisions criteria, determining go/no-go decisions for progressing a drug candidate to the next stage and predicting the effectiveness of a product. Lastly, it points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.
410  0$aSpringer Series in Pharmaceutical Statistics,$x2366-8695
606   $aStatistics 
606   $aBiostatistics
606   $aPharmacy
606   $aPharmaceutical technology
606   $aQuality control
606   $aReliability
606   $aIndustrial safety
606   $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030
606   $aBiostatistics$3https://scigraph.springernature.com/ontologies/product-market-codes/L15020
606   $aDrug Safety and Pharmacovigilance$3https://scigraph.springernature.com/ontologies/product-market-codes/H69010
606   $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010
606   $aQuality Control, Reliability, Safety and Risk$3https://scigraph.springernature.com/ontologies/product-market-codes/T22032
615  0$aStatistics .
615  0$aBiostatistics.
615  0$aPharmacy.
615  0$aPharmaceutical technology.
615  0$aQuality control.
615  0$aReliability.
615  0$aIndustrial safety.
615 14$aStatistics for Life Sciences, Medicine, Health Sciences.
615 24$aBiostatistics.
615 24$aDrug Safety and Pharmacovigilance.
615 24$aPharmaceutical Sciences/Technology.
615 24$aQuality Control, Reliability, Safety and Risk.
676   $a519.5
700   $aChuang-Stein$b Christy$4aut$4http://id.loc.gov/vocabulary/relators/aut$0766774
702   $aKirby$b Simon$4aut$4http://id.loc.gov/vocabulary/relators/aut
906   $aBOOK
912   $a9910254282103321
996   $aQuantitative Decisions in Drug Development$92283937
997   $aUNINA