ENGLISH

Statistics In Drug Research: Methodologies and Recent Developments (Biostatistics, 10)

By Shein-Chung Chow

Book information

Publisher
CRC Press
Year
2002
ISBN
082470763X, 9780824707637, 9780585419091
LCC
RS57 .C48 2002
Open Library ID
OL22482554M
Language
english
Format
PDF
Filesize
15 MB (15869005 bytes)
Edition
1
Pages
384\384
Scanned
yes
Time added
2011-08-31 04:54:40

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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