ENGLISH

Statistics in Drug Research: Methodologies and Recent Developments (Chapman & Hall/CRC Biostatistics Series)

By Shein-Chung Chow , Jun Shao

Book information

Publisher
CRC Press
Year
2002
ISBN
082470763X, 9780824707637
Language
english
Format
PDF
Filesize
18 MB (18991417 bytes)
Edition
1
Pages
384\372
Time added
2012-10-29 21:00:00

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.

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