Basic Statistics and Pharmaceutical Statistical Applications details the methodology necessary to summarize data and make informed decisions about observed outcomes.

Features:

• Measures of association primarily with nominal and ordinal data and and more than 15 tests
• Survival statistics including actuarial analysis and an introduction to multiple regression with survival data using proportional hazards regression
• An introduction to the topic of evidence-based practice with discussions of sensitivity and specificity, predictive values, and likelihood ratios
• Odds ratios and relative risk ratios that provide valuable information for dealing with probability, odds, and risk

Contents

Introduction

• Types of Statistics
• Parameters and Statistics
• Sampling and Independent Observations
• Types of Variables
• Independent and Dependent Variables
• Selection of the Appropriate Statistical Test
• Procedures for Inferential Statistical Tests

Probability

• Classic Probability
• Probability Involving Two Variables
• Conditional Probability
• Probability Distribution
• Counting Techniques
• Binomial Distribution
• Poisson Distribution

Sampling

• Random Sampling
• Other Probability Sampling Procedures
• Precision, Accuracy and Bias
• Reliability and Validity

Presentation Modes

• Tabulation of Data
• Visual Displays for Discrete Variables
• Visual Displays for Continuous Variables
• Visual Displays for Two or More Continuous Variable

Measures of Central Tendency

• Centers of a Continuous Distribution
• Dispersion Within a Continuous Distribution
• Population versus Sample Measures of Central Tendency
• Measurements Related to the Sample Standard Deviation
• Trimmed Mean
• Alternative Computational Methods for Calculating Central Tendency

The Normal Distribution and Data Transformation

• The Normal Distribution
• Determining if the Distribution is Normal
• New! Data Transformations: An Overview
• New! Lognormal Transformation and the Geometric Mean
• New! Other Types of Transformations

Confidence Intervals and Tolerance Limits

• Sampling Distribution
• Standard Error of the Mean versus the Standard Deviation
• Confidence Intervals
• Statistical Control Charts
• New! Process Capability
• New! Tolerance Limits

Hypothesis Testing

Hypothesis Testing
• Types of Errors
• Type I Error
• Type II Error and Power
• New! Experimental Errors and Propagation of Errors

T-Tests

• Parametric Procedures
• The t-distribution
• One-tailed vs. Two-tailed Tests
• One-Sample t-tests
• Two-Sample t-tests
• New! Corrected Degrees of Freedom for Unequal Variances
• One-sample t-test Revisited for Critical Value
• Matched Pair t-Test (Difference t-Test)

One-Way Analysis of Variance

• Hypothesis Testing with the One-way ANOVA
• The F-distribution
• Test Statistic
• ANOVA Definitional Formula
• ANOVA Computational Formula
• Randomized Block Design
• Homogeniety of Variance

Multiple Comparison Tests

• Error Associated with Multiple t-tests
• Overview of Multiple Comparison Tests
• New! The q-statistic
• New! Planned Multiple Comparisons
• Bonferroni Adjustment
• New! Sidák test
• Dunn's Multiple Comparisons
• New! Dunnett's Test
• Post hoc Procedures
• New! Tukey HSD Test
• Student Newman-Keuls Test
• New! Fisher LSD Test
• Scheffé Procedure
• Scheffé Procedure for Complex Comparisons
• New! Unbalanced Designs
• Lack of Homogeneity
• New! Other Post hoc Tests

Factorial Designs: An Introduction

• Factorial Designs
• Two-way Analysis of Variance
• Computational Formula with Unequal Cell Size
• Post Hoc Procedures
• New! Repeated Measures Design
• New! Repeatability and Reproducibility
• New! Latin Square Designs
• New! Fixed, Random and Mixed Effect Models
• Beyond a Two-way Factorial Design

Correlation

• Graphic Representation of Two Continuous Variables
• Pearson Product Moment Correlation Coefficient
• Correlation Line
• Statistical Significance of a Correlation Coefficient
• Correlation and Causality
• In vivo - In vitro Correlation
• New! Other Types of Bivariate Correlations
• Pair-wise Correlations Involving More Than Two Variables
• Multiple Correlations
• Partial Correlations
• Non-linear Correlations
• New! Assessing Independence and Randomness

Linear Regression

• Regression Line
• Coefficient of Determination
• ANOVA Table
• Confidence Intervals and Hypothesis Testing for the Population Slope (b)
• Confidence Intervals for the Regression Line
• New! Inverse Prediction
• New! Multiple Data at Various Points on the Independent Variable
• New! Assessing Parallelism of the Slopes of Two Sample
• Multiple Linear Regression Models

Z-Tests of Proportions

• z-test of Proportions - One-sample Case
• z-test of Proportions - Two-sample Case
• New! Estimating Power and Desired Sample size for two-sample Z-test of Proportions
• z-tests for Proportions - Yates' Correction for Continuity
• Proportion Testing for More Than Two Levels of a Discrete
• Independent Variable

Chi Square Tests

• Chi Square Statistic
• Chi Square for One Discrete Independent Variable
• Chi Square Goodness-of-fit Test
• Chi Square Test of Independence
• Yates' Correction for 2x2 Contingency Table
• New! Comparison of Chi Square to the Z-test of Proportions
• Fisher's Exact Test
• McNemar's Test
• Cochran's Q Test
• Mantel-Haenszel Test

Measures of Association

• Dichotomous Associations
• Nominal Associations
• Ordinal Associations
• Nominal-by-interval Associations
• Reliability Measurements

Odds Ratios and Relative Risk Ratios

• Probability, Odds, and Risk
• Odds Ratio
• Relative Risk
• Graphic Display for Odds Ratios and Relative Risk Ratios
• Mantel-Haenszel Estimate of Relative Risk
• Logistic Regression

Evidence-Based Practice: An Introduction

• Sensitivity and Specificity
• Two-by-Two Contingency Table
• Defining Evidence Based Practice
• Frequentist versus Bayesian Approaches to Probability
• Predictive Values
• Likelihood Ratios

Survival Statistics

• Censored Survival Data
• Life Table Analysis
• Survival Curve
• Kaplan-Meier Procedure
• Visually Comparison of Two Survival Curves
• Tests to Compare Two Levels of an Independent Variable
• Hazard Ratio
• Multiple Regression with Survival Data
• Proportional Hazards Regression
• Other Measures and Tests of Survival

Nonparametric Tests

• Use of Nonparametric Tests
• Ranking of Information
• Mann-Whitney U Test
• Median Test
• Wilcoxon Matched-Pairs Test
• Sign Test
• Kruskal-Wallis Test
• Post hoc Comparisons using Kruskal-Wallis
• Friedman Two-Way Analysis of Variance
• Spearman Rank-Order Correlation
• Theil's Incomplete Method
• Kolmogorov-Smirnov Goodness-of-Fit Test
• Anderson-Darling Test
• Runs Tests
• Range Tests

Statistical Tests for Equivalence

• Bioequivalence Testing
• Experimental Designs for Bioequivalence Studies
• Two-sample t-test Example
• Power in Bioequivalence Tests
• Rules for Bioequivalence
• Creating Confidence Intervals
• Comparison Using Two One-sided t-tests
• Clinical Equivalence and Non-inferiority
• Dissolution Testing
• SUPAC-IR Guidance

Outlier Tests

• Regulatory Considerations
• Outliers on a Single Continuum
• Plotting and Number of Standard Deviations from the Center
• The "Huge" Rule
• Grubbs' Test for Outlying Observations
• Dixon Q Test
• Hampel's Rule
• Multiple Outliers
• Bivariate Outliers in Correlation and Regression Analysis

Statistical Errors in the Literature

• Errors and the Peer Review Process
• Problems with Experimental Design
• Standard Deviations versus Standard Error of the Mean
• Problems with Hypothesis Testing
• Problems with Parametric Statistics
• Errors with the Chi Square Test of Independence

Index

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