Statistics in Drug Research: Methodologies and Recent Developments

Series:
Chapman & Hall/CRC Biostatistics Series
Published:
February 20, 2002 by CRC Press - 384 Pages
Author(s):
Shein-Chung Chow, Duke University School of Medicine, Durham, NC; Jun Shao, University of Wisconsin, Madison, USA

Purchasing Options

Hardback
$239.95
Add to cart
ISBN 9780824707637
Cat# DK5660
 

Features

  • Discusses shelf-life estimation of frozen drug products and the determination of shelf-life based on discrete response as well as for products with multiplecomponents
  • Covers statistical assessment of substantial evidence in clinical development and key concepts and statistical methodologies for medical imaging
  • Provides information on randomization, blinding, and statistical analysis under breached blindness
  • Includes meta-analysis emphasizing qualitative treatment-by-study interaction and analysis of incomplete data, including imputation and last observation carry-forward

    • Summary

    Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.

    Table of Contents

    Introduction
    Pharmaceutical Validation
    Dissolution Testing
    Stability Analysis
    Bioavailability and Bioequivalence
    Randomization and Blinding
    Substantial Evidence In Clinical Development
    Therapeutic Equivalence and Noninferiority
    Analysis of Incomplete Data
    Meta-Analysis
    Quality of Life
    Medical Imaging
    References
    Index

    Editorial Reviews

    "…a detailed examination of the issues and practices of this area of applied statistics."
    -Journal of Mathematical Psychology

    "[W]e can recommend this book as a reference which can help different groups to understand current methodologies and applications of statistics in drug industry. It provides a nice and clearly structured overview on each topic and may lower potential barriers for further studying each area."
    -ISCB News, December 2003

    Related Titles