This reference outlines important applications of statistics for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation in order to establish the safety and efficacy of pharmaceutical compounds.

From drug discovery and synthesis to regulatory registration and post-marketing surveillance, Statistics in Drug Research discusses:

• statistical techniques for assay validation and evaluation of drug performance characteristics such as content uniformity, disintegration, dissolution, and stability
• testing of population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines
• shelf-life estimation of frozen drug products and the determination of shelf-life based on discrete response as well as for products with multiplecomponents
• basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials
• statistical assessment of substantial evidence in clinical development
• key concepts and statistical methodologies for medical imaging
• randomization, blinding, and statistical analysis under breached blindness
• meta-analysis emphasizing qualitative treatment-by-study interaction
• analysis of incomplete data, including imputation and last observation carry-forward

Reinforcing the role of good statistical practices (GSP) in drug research and formulation, Statistics in Drug Research is an essential source for 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.

Contents

1. Introduction
2. Pharmaceutical Validation
3. Dissolution Testing
4. Stability Analysis
5. Bioavailability and Bioequivalence
6. Randomization and Blinding
7. Substantial Evidence In Clinical Development
8. Therapeutic Equivalence and Noninferiority
9. Analysis of Incomplete Data
10. Meta-Analysis
11. Quality of Life
12. Medical Imaging

Index

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