New drug development : design, methodology, and analysis /

New drug development : design, methodology, and analysis /

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Bibliographic Details
Main Author: Turner, J. Rick
Format: Book
Language:English
Published: Hoboken, N.J. : Wiley-Interscience, [2007]
Series:Statistics in practice.
Subjects:
Drug development.
Pharmacy.
Clinical Trials as Topic.
Pharmaceutical Preparations > chemical synthesis.
Drug Industry > methods.
Statistics.
Table of Contents:
  • New drug development
  • The regulatory environment for new drug development
  • Drug discovery
  • Nonclinical research
  • Design and methodology in clinical trials
  • Statistical analysis
  • Statistical significance : employment of hypothesis testing
  • Clinical significance : employment of confidence intervals
  • Sample-size estimation
  • Safety assessment in clinical trials
  • Efficacy assessment in clinical trials
  • Pharmaceutical and biopharmaceutical drug manufacturing
  • Postmarketing surveillance and evidence-based medicine
  • Unifying themes and concluding comments.