Pharmaceutical Statistics Practical and Clinical Applications, Fifth Edition

Through the use of practical examples and solutions, this timely "Fifth Edition "has been updated and expanded to provide the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly clinical trials and bioequivalence studies. New to the "Fifth Edition":

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 ConceptsVariables 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 ForNormally Distributed Variables Determination Of Sample Size For Binomial Tests Determination Of Sample Size To Obtain A Confidence Interval Of SpecifiedWidth 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 LinearRegression Assumptions In Tests Of Hypotheses In Linear Regression Estimate Of The Variance: Variance Of Sample Estimates Of TheParameters A Drug Stability Study: A Second Example Of The Application Of LinearRegression 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 FixedAnd 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 IndependentGroups) 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 RelativeAppendix 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