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

✍ Scribed by Shein-Chung Chow

• Publisher: CRC Press
• Year: 2002
• Tongue: English
• Leaves: 384
• Edition: 1
• Category: Library

✦ Synopsis

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.

✦ Table of Contents

Cover
......Page 1
Statistics In Drug Research: Methodologies and Recent Developments......Page 4
082470763X......Page 5
Contents......Page 10
1 Introduction......Page 18
2 Pharmaceutical Validation......Page 48
3 Dissolution Testing......Page 70
4 Stability Analysis......Page 94
5 Bioavailability and Bioequivalence......Page 124
6 Randomization and Blinding......Page 164
7 Substantial Evidence in Clinical Development......Page 186
8 Therapeutic Equivalence and Noninferiority......Page 214
9 Analysis of Incomplete Data......Page 246
10 Meta-Analysis......Page 274
11 Quality of Life......Page 302
12 Medical Imaging......Page 328
References......Page 360
Index......Page 380