Statistics in Drug Research: Methodologies and Recent Developments (Hardcover) (ISBN-13: 9780824707637)

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.

Author: Shein-Chung Chow,Jun Shao
ISBN-10: 082470763X
ISBN-13: 9780824707637
Publisher: CRC Press
Language: English
Published: 02/20/2002
Pages: 384
Format: Hardcover
Weight: 1.52lbs
Size: 9.49h x 6.47w x 1.08d