Shein-Chung Chow, Jun Shao

Statistics in Drug Research

Methodologies and Recent Developments

• Gebundenes Buch

Produktbeschreibung

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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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 388
• Erscheinungstermin: 20. Februar 2002
• Englisch
• Abmessung: 240mm x 161mm x 25mm
• Gewicht: 748g
• ISBN-13: 9780824707637
• ISBN-10: 082470763X
• Artikelnr.: 22320783

Autorenporträt

Chow, Shein-Chung; Shao, Jun

Inhaltsangabe

Introduction. harmaceutical 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.