rdf-syntax-grammar
mods:
  schema location: http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
  title info:
    title: Quantitative Decisions in Drug Development
  name:
    name part: Chuang-Stein, Christy.
    role:
      role term: creator
    role:
      role term: author.
  name:
    name part: Kirby, Simon.
    role:
      role term: author.
  name:
    name part: SpringerLink (Online service)
  type of resource: text
  origin info:
    place:
      place term: gw
    date issued: 2017
    issuance: monographic
  language:
    language term: eng
  physical description:
    form: electronic
    form: electronic resource
    reformatting quality: access
    form: remote
    extent: XV, 248 p. 27 illus., 11 illus. in color. online resource.
  abstract: 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.
  table 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.
  note: by Christy Chuang-Stein, Simon Kirby.
  subject:
    topic: Statistics
  subject:
    topic: Pharmaceutical technology
  subject:
    topic: Pharmacy
  subject:
    topic: Biostatistics
  subject:
    topic: Quality control
  subject:
    topic: Reliability
  subject:
    topic: Industrial safety
  subject:
    topic: Statistics
  subject:
    topic: Statistics for Life Sciences, Medicine, Health Sciences
  subject:
    topic: Biostatistics
  subject:
    topic: Drug Safety and Pharmacovigilance
  subject:
    topic: Pharmaceutical Sciences/Technology
  subject:
    topic: Quality Control, Reliability, Safety and Risk
  classification: QA276-280
  classification: 519.5
  related item:
    title info:
      title: Springer eBooks
  related item:
    title info:
      title: Springer Series in Pharmaceutical Statistics
  identifier: 9783319460765
  identifier: http://dx.doi.org/10.1007/978-3-319-46076-5
  record info:
    record creation date: 170525
    record change date: 20170525114034.0
    record identifier: 978-3-319-46076-5