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Statistics in Drug Research: Methodologies and Recent Developments

Autor Shein-Chung Chow, Jun Shao
en Limba Engleză Hardback – 20 feb 2002
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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Specificații

ISBN-13: 9780824707637
ISBN-10: 082470763X
Pagini: 384
Dimensiuni: 156 x 234 x 27 mm
Greutate: 0.87 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press

Public țintă

Professional Practice & Development

Cuprins

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.

Descriere

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.