  # Pharmaceutical Statistics

## Practical and Clinical Applications, Fifth Edition, 5th Edition

CRC Press

670 pages | 180 B/W Illus.

Hardback: 9781420074222
pub: 2009-12-23
\$230.00
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eBook (VitalSource) : 9780429147678
pub: 2009-12-23
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### Description

Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.

Basic Definitions and Concepts

Variables and Variation

Frequency Distributions and Cumulative Frequency Distributions

Sample and Population

Measures Describing the Center of Data Distributions

Measurement of the Spread of Data

Coding

Precision, Accuracy, and Bias

The Question of Significant Figures

Key Terms

Exercises

References

Data Graphics

Introduction

The Histogram

Construction and Labeling of Graphs

Scatter Plots (Correlation Diagrams)

Semilogarithmic Plots

Other Descriptive Figures

Key Terms

Exercises

References

Introduction to Probability: The Binomial and Normal Probability Distributions

Introduction

Some Basic Probability

Probability Distributions—The Binomial Distribution

Continuous Data Distributions

Other Common Probability Distributions

The Log-Normal Distribution

Key Terms

Exercises

References

Choosing Samples

Introduction

Random Sampling

Other Sampling Procedures: Stratified, Systematic, And Cluster Sampling

Sampling in Quality Control

Key Terms

Exercises

References

Statistical Inference: Estimation and Hypothesis Testing

Statistical Estimation (Confidence Intervals)

Statistical Hypothesis Testing

Comparison Of Variances In Independent Samples

Test Of Equality Of More Than Two Variances

Confidence Limits For A Variance

Tolerance Intervals

Key Terms

Exercises

References

Sample Size and Power

Introduction

Determination Of Sample Size For Simple Comparative Experiments For

Normally Distributed Variables

Determination Of Sample Size For Binomial Tests

Determination Of Sample Size To Obtain A Confidence Interval Of Specified

Width

Power

Sample Size And Power For More Than Two Treatments (Also See Chap. )

Sample Size For Bioequivalence Studies (Also See Chap. )

Key Terms

Exercises

References

Linear Regression and Correlation

Introduction

Analysis Of Standard Curves In Drug Analysis: Application Of Linear

Regression

Assumptions In Tests Of Hypotheses In Linear Regression

Estimate Of The Variance: Variance Of Sample Estimates Of The

Parameters

A Drug Stability Study: A Second Example Of The Application Of Linear

Regression

Confidence Intervals In Regression Analysis

Weighted Regression

Analysis Of Residuals

Nonlinear Regression

. Correlation

. Comparison Of Variances In Related Samples

Key Terms

Exercises

References

Analysis of Variance

One-Way Anova

Planned Versus A Posteriori (Unplanned) Comparisons In Anova

Another Example Of One-Way Anova: Unequal Sample Sizes And The Fixed

And Random Models

Two-Way Anova (Randomized Blocks)

Statistical Models∗∗

Analysis Of Covariance∗∗

Anova For Pooling Regression Lines As Related To Stability Data∗∗

Key Terms

Exercises

References

Factorial Designs∗∗

Definitions (Vocabulary)

Two Simple Hypothetical Experiments To Illustrate The Advantages Of Factorial Designs

Performing Factorial Experiments: Recommendations And Notation

AWorked Example Of A Factorial Experiment

Fractional Factorial Designs

Key Terms

Exercises

References

Transformations and Outliers

Transformations

Outliers

Key Terms

Exercises

References

Introduction

Some Principles Of Experimental Design And Analysis

Parallel Design

Crossover Designs And Bioavailability/Bioequivalence Studies

Repeated Measures (Split-Plot) Designs

Multiclinic Studies

Interim Analyses

Key Terms

Exercises

References

Quality Control

Introduction

Control Charts

Acceptance Sampling And Operating Characteristic Curves

Statistical Procedures In Assay Development

Establishing In-House Limits

Some Statistical Aspects Of Quality And The "Barr Decision"

Important QC Tests For Finished Solid Dosage Forms

(Tablets And Capsules)

Out Of Specification (OOS) Results

Key Terms

Exercises

References

Validation

Process Validation

Assay Validation

Concluding Remarks

Key Terms

Exercises

References

Computer-Intensive Methods

Monte Carlo Simulation

Bootstrapping

References

Nonparametric Methods

Data Characteristics And An Introduction To Nonparametric Procedures

Sign Test

Wilcoxon Signed Rank Test

Wilcoxon Rank Sum Test (Test For Differences Between Two Independent

Groups)

Kruskal–Wallis Test (One-Way Anova)

Friedman Test (Two-Way Analysis Of Variance)

Nonparametric Analysis Of Covariance

Runs Test For Randomness

Contingency Tables

Nonparametric Tolerance Interval

Key Terms

Exercises

References

Optimization Techniques and Screening Designs∗∗

Introduction

Optimization Using Factorial Designs

Composite Designs To Estimate Curvature

The Simplex Lattice

Sequential Optimization**

Screening Designs

Key Terms

Exercises

References

Glossary

Appendix I: Some Properties of the Variance

Appendix II: Comparison of Slopes and Testing of Linearity: Determination of Relative

Appendix III: Multiple Regression

Appendix IV: Tables

Appendix V: Outlier Tests and Chemical Assays

Appendix VI: Should a Single Unexplained Failing Assay be Reason to Reject a Batch?

Appendix VII: When is it Appropriate to Average and its Relationship to the Barr Decision

Appendix VIII: Excel Workbooks and SAS Programs

Appendix IX: An Alternative Solution to the Distribution of the Individual Bioequivalence Metric

Appendix X: Some Statistical Considerations and Alternate Designs and Considerations for Bioequivalence