Statistics in Drug Research: Methodologies and Recent Developments

Statistics in Drug Research: Methodologies and Recent Developments

by Shein-Chung Chow, Jun Shao, Chow Chow
     
 

ISBN-10: 082470763X

ISBN-13: 9780824707637

Pub. Date: 02/01/2002

Publisher: Taylor & Francis

This reference outlines important applications of statistics for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation in order to establish the safety and efficacy of pharmaceutical compounds. Reinforcing the role of good statistical practices (GSP) in drug research and formulation,

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Overview

This reference outlines important applications of statistics for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation in order to establish the safety and efficacy of pharmaceutical compounds. Reinforcing the role of good statistical practices (GSP) in drug research and formulation, Statistics in Drug Research is an essential source for biostatisticians; pharmacologists; clinical, industrial, and research pharmacists; statisticians and applied statisticians; biometricians; quality control personnel; drug regulatory personnel; and upper-level undergraduate and graduate students in these disciplines.

Product Details

ISBN-13:
9780824707637
Publisher:
Taylor & Francis
Publication date:
02/01/2002
Series:
Chapman & Hall/CRC Biostatistics Series
Pages:
384
Product dimensions:
9.21(w) x 6.14(h) x 0.88(d)

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

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