Statistics in Drug Research: Methodologies and Recent Developments (Paperback) (ISBN-13: 9780367396336)

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: 0367396335
ISBN-13: 9780367396336
Publisher: CRC Press
Language: English
Published: 09/05/2019
Pages: 388
Format: Paperback
Weight: 0.80lbs
Size: 9.20h x 6.20w x 0.70d