ENGLISH

Statistics in Drug Research: Methodologies and Recent Developments

By Shein-Chung Chow , Jun Shao

Book information

Publisher
CRC Press
Year
2002
ISBN
9780824707637, 082470763X
LCC
RS57 .C48 2002
Open Library ID
OL22482554M
Language
english
Format
PDF
Filesize
18 MB (19220844 bytes)
Series
Chapman & Hall/CRC Biostatistics Series
Edition
1
Pages
372\372
Library
mexmat
Time added
2009-11-09 02:42:13

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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