Features Discusses shelf-life estimation of frozen drug products and the determination of shelf-life based on discrete response as well as for products with multiplecomponents Covers statistical assessment of substantial evidence in clinical development and key concepts and statistical methodologies for medical imaging Provides information on randomization, blinding, and statistical analysis under breached blindness Includes meta-analysis emphasizing qualitative treatment-by-study interaction and analysis of incomplete data, including imputation and last observation carry-forward
Summary 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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