Statistics in Drug Research: Methodologies and Recent Developments

ISBN-13: 9780367396336 / Angielski / Miękka / 2019 / 384 str.

Shein-Chung Chow; Jun Shao

Opis

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.

Spis treści

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.

O autorze

Chow, Shein-Chung; Shao, Jun