Statistics in Drug Research : Methodologies and Recent Developments book cover
1st Edition

Statistics in Drug Research
Methodologies and Recent Developments

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ISBN 9780824707637
Published February 20, 2002 by CRC Press
384 Pages

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Book Description

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. harmaceutical 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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Chow, Shein-Chung; Shao, Jun