Statistics in Drug Research: Methodologies and Recent Developments

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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.

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Editorial Reviews

From The Critics
Chow (Temple U.) and Shao (U. of Wisconsin-Madison) explain the application of statistics used during the various stages of pharmaceutical research and development to demonstrate quality, safety, and efficacy in research and development. Among the contexts they consider are assay and process validation, dissolution testing and profile comparison, stability analysis, and bioavailability and bioequivalence. They draw on such principles as randomization, blinding, substantive evidence, bridging studies, therapeutic equivalence, noninferiority trials, analyzing incomplete data, meta- analysis, quality of life, and medical imaging. Annotation c. Book News, Inc., Portland, OR (
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Product Details

Table of Contents

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
Quality of Life
Medical Imaging

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