Fourth Edition
includes CD-ROM
by Sanford Bolton and Charles Bon

The global appeal of Pharmaceutical Statistics lies in its ability to streamline modern principles and practices in statistics for direct use in pharmaceutical research and clinical evaluation.

This Fourth Edition logs recent changes in pharmaceutical process methods—offering computer-intensive approaches and new treatments of key concepts—while continuing to meet the needs of the pharmaceutical research community through clear explication of statistical terms, reference to current FDA operations, and illustrative problem-solution pairs.

Adding even more figures, tables, equations, and literature citations into its reader-friendly format, the Fourth Edition presents:

• a new chapter on simulation techniques useful for solving complex probabilistic and statistical problems
• explores issues in quality control and process and assay validation in expanded detail
• broadens discussion of bioequivalence study procedures and analysis, attending especially to replicate designs, crossover designs, and individual bioequivalence
• offers novel insight into averaging in view of the Barr decision
• sharpens understanding of the drug product stability, exploring prediction of shelf-life and overage as well as bracketing and matrix designs
• conveys contemporary notions of content uniformity and release targets
• elaborates on the statistical constitution of clinical trials, from interim and carry-forward analyses to group sequential methods and multiple tests
• freshly addresses nonparametric tests, optimization, and sample size considerations

Pharmaceutical Statistics 4th Edition includes a CD-ROM with special programs to aid in problem analysis. Presents fresh material on concept conformity and release targets. Describes linear regression and correlation, the analysis of variance, and crossover designs.

Contents

1. Basic Definitions and Concepts
2. Data Graphics
3. Introduction to Probability: The Binomial and Normal Probability Distributions
4. Choosing Samples
5. Statistical Inference: Estimation and Hypothesis Testing
6. Sample Size and Power
7. Linear Regression and Correlation
8. Analysis of Variance
9. Factorial Designs
10. Transformations and Outliers
11. Experimental Design in Clinical Trials
12. Quality Control
13. Validation
14. Computer-Intensive Methods
15. Nonparametric Methods
16. Optimization Techniques and Screening Designs

Appendices

• Some Properties of the Variance
  
• Comparison of Slopes and Testing of Linearity: Determination of Relative Potency
  
• Multiple Regression
  
• Tables
  
• Outlier Tests and Chemical Assays
  
• Should a Single Unexplained Failing Assay Be Reason to Reject a Batch?
• When it is Appropriate to Average and its Relationship to the Barr Decision
• Excel Workbooks and SAS Programs
• An Alternative Solution to the Distribution of the Individual Bioequivalence Metric

Answers to Exercises
Index

click here to see books • videos • cd-roms of related interest