LEADER 00991nam0-22003251i-450 001 990001612200403321 005 20200427105300.0 035 $a000161220 035 $aFED01000161220 035 $a(Aleph)000161220FED01 035 $a000161220 100 $a20030910d1981----km-y0itay50------ba 101 0 $aita 200 1 $aCooperative di produzione e agricoltura di gruppo$fGiorgio Amadei, Guido Corazziari, Arianna Montanari 210 $aMilano$cFrancoAngeli$d1981 215 $a418 p.$d22 cm 610 0 $aCooperazione agricola 676 $a334.683 700 1$aAmadei,$bGiorgio$f<1937- >$0303746 701 1$aCorazziari,$bGuido$068621 701 1$aMontanari,$bArianna$068622 801 0$aIT$bUNINA$gREICAT$2UNIMARC 901 $aBK 912 $a990001612200403321 952 $a60 334.68 AMAG 1981$b48060$fFAGBC 952 $aXV R 223$bS.I.$fDTE 959 $aFAGBC 959 $aDTE 996 $aCooperative di produzione e agricoltura di gruppo$9369167 997 $aUNINA LEADER 05452nam 22006735 450 001 9910497090203321 005 20250326144031.0 010 $a9783030797317 010 $a3030797317 024 7 $a10.1007/978-3-030-79731-7 035 $a(CKB)5590000000552004 035 $a(MiAaPQ)EBC6719962 035 $a(Au-PeEL)EBL6719962 035 $a(OCoLC)1267337314 035 $a(PPN)258054778 035 $a(DE-He213)978-3-030-79731-7 035 $a(EXLCZ)995590000000552004 100 $a20210903d2021 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aQuantitative Decisions in Drug Development /$fby Christy Chuang-Stein, Simon Kirby 205 $a2nd ed. 2021. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2021. 215 $a1 online resource (354 pages) 225 1 $aSpringer Series in Pharmaceutical Statistics,$x2366-8709 311 08$a9783030797300 311 08$a3030797309 327 $aChapter 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. 330 $aThis 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 historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria tothe cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. 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. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book 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,$x2366-8709 606 $aStatistics 606 $aBiometry 606 $aSampling (Statistics) 606 $aPharmacology 606 $aStatistical Theory and Methods 606 $aBiostatistics 606 $aMethodology of Data Collection and Processing 606 $aPharmacology 615 0$aStatistics. 615 0$aBiometry. 615 0$aSampling (Statistics) 615 0$aPharmacology. 615 14$aStatistical Theory and Methods. 615 24$aBiostatistics. 615 24$aMethodology of Data Collection and Processing. 615 24$aPharmacology. 676 $a615.19 700 $aChuang-Stein$b Christy$0766774 702 $aKirby$b Simon 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910497090203321 996 $aQuantitative Decisions in Drug Development$92283937 997 $aUNINA