New drug development : design, methodology, and analysis /

Bibliographic Details
Main Author: Turner, J. Rick
Format: Book
Published: Hoboken, N.J. : Wiley-Interscience, [2007]
Series:Statistics in practice.
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.