ABSTRACT

The fourth edition of a bestselling text, this book covers the use of statistics in pharmaceutical research and clinical evaluation. It includes a disk with special prograns to aid in problem analysis. The coverage progresses from basic definitions and concepts, data graphics, and probability through ANOVA, factorial designs, and optimization techniques. The discussion and examples have been expanded to include GMPs, validation, and quality control, as well as procedures and analyses in bioequivalence studies. The text presents fresh material on concept conformity and release targets and describes linear regression and correlation, the analysis of variance, and crossover designs.

chapter 1|30 pages

BASIC DEFINITIONS AND CONCEPTS

chapter 2|18 pages

DATA GRAPHICS

chapter 4|14 pages

CHOOSING SAMPLES

chapter 6|22 pages

SAMPLE SIZE AND POWER

chapter 7|42 pages

LINEAR REGRESSION AND CORRELATION

chapter 8|50 pages

ANALYSIS OF VARIANCE

chapter 9|24 pages

Factorial Designs**

chapter 10|22 pages

TRANSFORMATIONS AND OUTLIERS

chapter |62 pages

EXPERIMENTAL DESIGN IN CLINICAL TRIALS

chapter 12|43 pages

QUALITY CONTROL

chapter 13|48 pages

VALIDATION

chapter 15|42 pages

NONPARAMETRIC METHODS

chapter |2 pages

GLOSSARY

chapter |6 pages

Appendix III: Multiple Regression

chapter |21 pages

Appendix IV: Tables

chapter |21 pages

ANSWERS TO EXERCISES