Preface | p. v |
Basic Definitions and Concepts | p. 1 |
Variables and Variation | p. 1 |
Frequency Distributions and Cumulative Frequency Distributions | p. 4 |
Sample and Population | p. 9 |
Measures Describing the Center of Data Distributions | p. 12 |
Measurement of the Spread of Data | p. 16 |
Coding | p. 22 |
Precision, Accuracy, and Bias | p. 24 |
The Question of Significant Figures | p. 27 |
Data Graphics | p. 31 |
Introduction | p. 31 |
The Histogram | p. 32 |
Construction and Labeling of Graphs | p. 33 |
Scatter Plots (Correlation Diagrams) | p. 40 |
Semilogarithmic Plots | p. 42 |
Other Descriptive Figures | p. 43 |
Introduction to Probability: The Binomial and Normal Probability Distributions | p. 49 |
Introduction | p. 49 |
Some Basic Probability | p. 50 |
Probability Distributions--The Binomial Distribution | p. 54 |
Continuous Data Distributions | p. 63 |
Other Common Probability Distributions | p. 76 |
Choosing Samples | p. 82 |
Introduction | p. 82 |
Random Sampling | p. 83 |
Other Sampling Procedures: Stratified, Systematic, and Cluster Sampling | p. 88 |
Sampling in Quality Control | p. 90 |
Statistical Inference: Estimation and Hypothesis Testing | p. 96 |
Statistical Estimation (Confidence Intervals) | p. 96 |
Statistical Hypothesis Testing | p. 104 |
Comparison of Variances in Independent Samples | p. 139 |
Test of Equality of More than Two Variances | p. 141 |
Confidence Limits for a Variance | p. 142 |
Tolerance Intervals | p. 144 |
Sample Size and Power | p. 151 |
Introduction | p. 151 |
Determination of Sample Size for Simple Comparative Experiments for Normally Distributed Variables | p. 153 |
Determination of Sample Size for Binomial Tests | p. 159 |
Determination of Sample Size to Obtain a Confidence Interval of Specified Width | p. 161 |
Power | p. 162 |
Sample Size and Power for More than Two Treatments | p. 166 |
Sample Size for Bioequivalence Studies | p. 168 |
Linear Regression and Correlation | p. 173 |
Introduction | p. 174 |
Analysis of Standard Curves in Drug Analysis: Application of Linear Regression | p. 178 |
Assumptions in Tests of Hypotheses in Linear Regression | p. 179 |
Estimate of the Variance: Variance of Sample Estimates of the Parameters | p. 181 |
A Drug Stability Study: A Second Example of the Application of Linear Regression | p. 183 |
Confidence Intervals in Regression Analysis | p. 189 |
Weighted Regression | p. 193 |
Analysis of Residuals | p. 195 |
Nonlinear Regression | p. 197 |
Correlation | p. 200 |
Comparison of Variances in Related Samples | p. 208 |
Analysis of Variance | p. 215 |
One-Way Analysis of Variance | p. 215 |
Planned Versus a Posteriori (Unplanned) Comparisons in ANOVA | p. 222 |
Another Example of One-Way Analysis of Variance: Unequal Sample Sizes and the Fixed and Random Models | p. 232 |
Two-Way Analysis of Variance (Randomized Blocks) | p. 234 |
Statistical Models | p. 249 |
Analysis of Covariance | p. 250 |
ANOVA for Pooling Regression Lines as Related to Stability Data | p. 256 |
Factorial Designs | p. 265 |
Definitions (Vocabulary) | p. 265 |
Two Simple Hypothetical Experiments to Illustrate the Advantages of Factorial Designs | p. 270 |
Performing Factorial Experiments: Recommendations and Notation | p. 273 |
A Worked Example of a Factorial Experiment | p. 275 |
Fractional Factorial Designs | p. 281 |
Some General Comments | p. 285 |
Transformations and Outliers | p. 289 |
Transformations | p. 290 |
Outliers | p. 300 |
Experimental Design in Clinical Trials | p. 311 |
Introduction | p. 311 |
Some Principles of Experimental Design and Analysis | p. 312 |
Parallel Design | p. 317 |
Crossover Designs and Bioavailability/Bioequivalence Studies | p. 321 |
Repeated Measures (Split-Plot) Designs | p. 360 |
Multiclinic Studies | p. 365 |
Interim Analyses | p. 367 |
Quality Control | p. 373 |
Introduction | p. 373 |
Control Charts | p. 374 |
Acceptance Sampling and Operating Characteristic Curves | p. 388 |
Statistical Procedures in Assay Development | p. 391 |
Establishing In-House Limits | p. 401 |
Some Statistical Aspects of Quality and the "Barr Decision" | p. 404 |
Important QC Tests for Finished Solid Dosage Forms (Tablets and Capsules) | p. 408 |
Out of Specification (00S) Results | |
Validation | p. 416 |
Process Validation | p. 416 |
Assay Validation | p. 428 |
Concluding Remarks | p. 435 |
Computer Intensive Methods | p. 437 |
Monte Carlo Simulation | p. 438 |
Bootstrapping | p. 458 |
Nonparametric Methods | p. 464 |
Data Characteristics and an Introduction to Nonparametric Procedures | p. 464 |
Sign Test | p. 467 |
Wilcoxon Signed Rank Test | p. 469 |
Wilcoxon Rank Sum Test (Test for Differences Between Two Independent Groups) | p. 473 |
Kruskal--Wallis Test (One-Way ANOVA) | p. 479 |
Friedman Test (Two-Way Analysis of Variance) | p. 481 |
Nonparametric Analysis of Covariance | p. 485 |
Runs Test for Randomness | p. 486 |
Contingency Tables | p. 489 |
Non Parametric Tolerance Interval | p. 500 |
Optimization Techniques and Screening Designs** | p. 506 |
Introduction | p. 506 |
Optimization Using Factorial Designs | p. 508 |
Composite Designs to Estimate Curvature | p. 518 |
The Simplex Lattice | p. 523 |
Sequential Optimization | p. 531 |
Glossary | p. 540 |
Some Properties of the Variance | p. 542 |
Pooling Variances | p. 542 |
Components of Variance | p. 543 |
Variance of Linear Combinations of Independent Variables | p. 543 |
Comparison of Slopes and Testing of Linearity: Determination of Relative Potency | p. 545 |
Multiple Regression | p. 551 |
Tables | p. 557 |
Random Numbers | p. 557 |
Cumulative Normal Distribution Cumulative Area Under the Normal Distribution (Less Than or Equal to Z) | p. 558 |
Individual Terms of the Binomial Distribution for N = 2 to 10 and P = 0.2, 0.5, and 0.7 | p. 559 |
t Distributions | p. 561 |
Short Table of Chi-Square Distributions | p. 561 |
Upper 5% Values of the F Distribution | p. 562 |
Short Table of Upper 1% Values of the F Distribution | p. 563 |
Upper 5% Points in the Studentized Range | p. 564 |
Values of t' for Dunnett's Comparison of Several Treatments and a Control ([alpha] = 0.05) | p. 564 |
Dixon's Criteria for Rejecting Outliers | p. 565 |
Critical Values of T for a Two-Sided Test at the 5% Level of Significance (Test for Outliers) | p. 566 |
Factors for Determining Upper and Lower 3[sigma] Limits for Mean (X) and Range (R) Charts, and for Estimating [sigma] from R | p. 567 |
Number of Correct Guesses Needed for Significance in the Triangle Test | p. 568 |
Number of Positive or Negative Signs Needed for Significance for the Sign Test | p. 568 |
Values Leading to Significance for the Wilcoxon Signed Rank Test (Two-Sided Test) | p. 569 |
Critical Values for Number of Runs at the 5% Level of Significance | p. 569 |
Probability of Getting at Least One Run of Given Size for N Samples | p. 570 |
Critical Values for Wilcoxon Rank Sum Test ([alpha] = 0.05) | p. 570 |
Critical Differences for Significance ([alpha] = 0.05) Comparing All Possible Pairs of Treatments for Nonparametric One-Way ANOVA | p. 571 |
Critical Differences for Significance ([alpha] = 0.05) Comparing All Possible Pairs of Treatments for Nonparametric Two-Way ANOVA | p. 572 |
Factors for Two-Sided Tolerance Limits for Normal Distributions | p. 573 |
Test for Outliers | p. 576 |
Outlier Tests and Chemical Assays | p. 578 |
Introduction | p. 578 |
Can Outlier Tests Be Justified? | p. 579 |
Why Is There Not a USP Test for Outliers for Chemical Assays? | p. 580 |
Some Comments on the Nature of Outliers and Outlier Tests, and Other Inconsistencies in the Decision That Outlier Tests Be Used for Biological Assays but Not for Chemical Assays | p. 581 |
What Is the Purpose of Performing Replicate Assays and When is Averaging Appropriate? | p. 582 |
In What Situations Might Outlier Tests Be Applicable? | p. 582 |
Should a Single Unexplained Failing Assay Be Reason to Reject a Batch? | p. 585 |
When it is Appropriate to Average and its Relationship to the Barr Decision | p. 594 |
Excel Workbooks and SAS Programs | p. 599 |
Excel Workbooks | p. 599 |
SAS Programs | p. 653 |
An Alternative Solution to the Distribution of the Individual Bioequivalence Metric | p. 711 |
Answers to Exercises | p. 722 |
Index | p. 743 |
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