Statistics in Drug Research: Methodologies and Recent Developments, 1st Edition (Hardback) book cover

Statistics in Drug Research

Methodologies and Recent Developments, 1st Edition

By Shein-Chung Chow, Jun Shao

CRC Press

384 pages

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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.

About the Authors

Chow, Shein-Chung; Shao, Jun

Subject Categories

BISAC Subject Codes/Headings:
MAT029000
MATHEMATICS / Probability & Statistics / General
MED071000
MEDICAL / Pharmacology