Chow / Shao Statistics in Drug Research

Methodologies and Recent Developments
1. Auflage 2002
ISBN: 978-0-203-91014-6
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 384 Seiten

Reihe: Chapman & Hall/CRC Biostatistics Series

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.

Zielgruppe

Biostatisticians; pharmacologists; clinical, industrial, and research pharmacists; statisticians and applied statisticians; biometricians; quality control personnel; drug regulatory personnel; and upper-level undergraduate and graduate students in these disciplines

Autoren/Hrsg.

Chow, Shein-Chung

Shao, Jun

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Naturwissenschaften Biowissenschaften Biowissenschaften

Inhaltsverzeichnis

Introduction
Pharmaceutical Validation
Dissolution Testing
Stability Analysis
Bioavailability and Bioequivalence
Randomization and Blinding
Substantial Evidence In Clinical Development
Therapeutic Equivalence and Noninferiority
Analysis of Incomplete Data
Meta-Analysis
Quality of Life
Medical Imaging
References
Index