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000782413 019__ $$a988377349
000782413 020__ $$a9783319460765$$q(electronic book)
000782413 020__ $$a3319460765$$q(electronic book)
000782413 020__ $$z9783319460758
000782413 020__ $$z3319460757
000782413 035__ $$aSP(OCoLC)ocn988292350
000782413 035__ $$aSP(OCoLC)988292350$$z(OCoLC)988377349
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000782413 050_4 $$aRM301.25
000782413 08204 $$a615.1/9$$223
000782413 08204 $$a519.5
000782413 1001_ $$aChuang-Stein, Christy.
000782413 24510 $$aQuantitative decisions in drug development /$$cChristy Chuang-Stein, Simon Kirby.
000782413 260__ $$aCham :$$bSpringer,$$c2017.
000782413 300__ $$a1 online resource.
000782413 336__ $$atext$$btxt$$2rdacontent
000782413 337__ $$acomputer$$bc$$2rdamedia
000782413 338__ $$aonline resource$$bcr$$2rdacarrier
000782413 4901_ $$aSpringer series in pharmaceutical statistics
000782413 5050_ $$aPreface; Contents; Chapter 1: Clinical Testing of a New Drug; 1.1 Introduction; 1.2 Clinical Development; 1.2.1 Phase 1; 1.2.2 Phase 2; 1.2.3 Phase 3; 1.2.4 Phase 4; 1.3 Regulatory Review; 1.3.1 Accelerated Approval; 1.3.2 Breakthrough Therapy; 1.3.3 Priority Review; 1.3.4 Fast Track; 1.3.5 Orphan Drug; 1.3.6 Drug Approval in the European Union (EU); 1.4 Innovative Designs; 1.4.1 Adaptive Design; 1.4.2 Master Protocol; 1.5 Summary; References; Chapter 2: A Frequentist Decision-Making Framework; 2.1 Introduction; 2.2 Statistical Hypotheses; 2.3 Testing a Statistical Hypothesis
000782413 5058_ $$a2.4 Decision-Making2.5 Losses and Risks; 2.6 The Power Function of a Test; 2.7 Determining a Sample Size for an Experiment; 2.8 Multistage Tests and the Use of a No-Decision Region; 2.9 One-Sided Versus Two-Sided Tests; 2.10 P-Values; 2.11 Summary; References; Chapter 3: Characteristics of a Diagnostic Test; 3.1 Introduction; 3.2 Sensitivity and Specificity; 3.3 Positive and Negative Predictive Value; 3.4 Value of a Follow-Up Test; 3.5 When Two Tests Are Being Done Simultaneously; 3.6 Summary; References; Chapter 4: The Parallel Between Clinical Trials and Diagnostic Tests; 4.1 Introduction
000782413 5058_ $$a4.2 Why Replication Is Necessary4.3 Why Replication Is Hard; 4.3.1 Conditional Replication Probability; 4.3.2 Average Replication Probability; 4.3.3 When the Second Trial Has a Different Sample Size; 4.4 Differentiate Between Statistical Power and the Probability of a Successful Trial; 4.5 Summary; References; Chapter 5: Incorporating Information from Completed Trials in Future Trial Planning; 5.1 Introduction; 5.2 The Bayesian Approach to Inference; 5.3 Bayesian Average Power and Assurance; 5.4 Closed-Form Expressions for Assurance and the Simulation Approach
000782413 5058_ $$a5.5 PPV and NPV for a Planned Trial5.6 Forming a Prior Distribution from a Number of Similar Previous Trials; 5.7 Standard Prior Distributions; 5.8 Elicitation of a Prior Distribution from Experts; 5.9 Prior Distributions from PK/PD Modeling and Model-Based Meta-Analysis; 5.10 Discussion; References; Chapter 6: Choosing Metrics Appropriate for Different Stages of Drug Development; 6.1 Introduction; 6.2 Metrics for Proof-of-Concept Studies; 6.3 Metrics for Dose-Ranging Studies; 6.3.1 Estimating a Dose-Response Relationship; 6.3.1.1 Emax Model; 6.3.1.2 Other Dose-Response Models
000782413 5058_ $$a6.3.2 Testing for a Positive Dose-Response Relationship6.3.3 Calculating the Metrics; 6.4 Metrics for Confirmatory Studies; 6.5 Other Types of Success Probabilities; 6.5.1 Probability of Program Success (POPS); 6.5.2 Probability of Compound Success (POCS); 6.6 Discussion; References; Chapter 7: Designing Proof-of-Concept Trials with Desired Characteristics; 7.1 Introduction; 7.2 Five Approaches to Decision-Making; 7.2.1 The Traditional Hypothesis-Testing Approach; 7.2.2 The ESoE Approach; 7.2.3 The LPDAT Approach; 7.2.4 The TV Approach; 7.2.5 The TVMCID Approach
000782413 506__ $$aAccess limited to authorized users.
000782413 588__ $$aDescription based on print version record.
000782413 650_0 $$aDrug development$$xDecision making.
000782413 650_0 $$aDrug development$$xEconomic aspects.
000782413 7001_ $$aKirby, Simon$$c(Economist)
000782413 77608 $$iPrint version:$$z3319460757$$z9783319460758$$w(OCoLC)956480185
000782413 830_0 $$aSpringer series in pharmaceutical statistics.
000782413 852__ $$bebk
000782413 85640 $$3SpringerLink$$uhttps://univsouthin.idm.oclc.org/login?url=http://link.springer.com/10.1007/978-3-319-46076-5$$zOnline Access$$91397441.1
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000782413 980__ $$aEBOOK
000782413 980__ $$aBIB
000782413 982__ $$aEbook
000782413 983__ $$aOnline
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