Chapter 1: Introduction; 1.1 Objectives; 1.2 Regulatory Guidance for CMC Applications; 1.3 Use of Statistical Tools in Pharmaceutical Development and Manufacturing; 1.4 Differences Between Clinical and CMC Statisticians; 1.5 How to Use This Book; References; Chapter 2: Statistical Methods for CMC Applications; 2.1 Introduction; 2.2 Statistical Analysis in a CMC Environment; 2.2.1 Initial Client Meeting; 2.2.2 Planning of Statistical Analysis; 2.2.2.1 Statement of the Study Objective; 2.2.2.2 Data Acquisition; 2.2.2.3 Selection of a Statistical Tool; 2.2.3 Data Analysis

2.2.3.1 Obtain the Data2.2.3.2 Plot the Data; 2.2.3.3 Estimate the Unknown Quantities of Interest; 2.2.3.4 Quantify the Uncertainty in the Point Estimates Using a Statistical Interval; 2.2.4 Communication of Results to Client; 2.3 Data Rounding and Reporting of Results; 2.4 Use of Tables and Graphs; 2.5 Statistical Intervals; 2.5.1 Confidence Intervals; 2.5.2 Prediction Intervals; 2.5.3 Tolerance Intervals; 2.5.4 Individual Versus Mean; 2.5.5 Formula Notation; 2.6 Intervals for One Population (Independent Measurements); 2.6.1 Confidence Interval for Mean

2.6.2 Confidence Interval for Variance2.6.3 Confidence Interval on the Standard Deviation; 2.6.4 Confidence Interval on the Percent Relative Standard Deviation; 2.6.5 Confidence Interval for Proportion Out of Specification; 2.6.6 Prediction Interval for the Next Observed Process Value; 2.6.7 Tolerance Interval for all Future Process Values; 2.6.8 Comparison of Statistical Intervals; 2.6.9 Data Sets with LOQ Values; 2.6.10 Non-Normal Data; 2.7 Intervals for One Population (Dependent Measurements); 2.7.1 Confidence Interval for Mean

2.7.2 Confidence Intervals for Individual Variances, the Sum of the Variances, and the Ratio2.7.3 Prediction Interval for the Next Observed Process Value; 2.7.4 Tolerance Interval for All Future Process Values; 2.7.5 Modifications for Unbalanced Designs; 2.8 Comparing Two Populations (Independent Measurements); 2.8.1 Confidence Interval for Difference in Means; 2.8.2 Confidence Interval for the Effect Size; 2.8.3 Confidence Interval for the Ratio of Two Variances; 2.9 Confidence Interval for Difference of Means (Dependent Measurements); 2.10 Basics of Hypothesis Testing

2.10.1 Statement of Hypotheses2.10.2 Testing Errors and Power; 2.10.3 Using Confidence Intervals to Conduct Statistical Tests; 2.10.4 Using p-Values to Conduct a Statistical Test; 2.11 Equivalence Testing; 2.12 Regression Analysis; 2.12.1 Linear Regression with One Predictor Variable; 2.12.2 Checking Regression Assumptions with Residual Plots; 2.12.3 Multiple Regression Analysis; 2.12.3.1 Model Definitions; 2.12.3.2 Regression Calculations; 2.12.4 Incorporating Interaction and Quadratic Effects; 2.12.5 Incorporating Qualitative Predictor Variables