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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
Some General Comments
Key Terms
Exercises
References
Transformations and Outliers
Transformations
Outliers
Key Terms
Exercises
References
Experimental Design in Clinical Trials
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
Answer to Exercises