Pharmaceutical statistics : practical and clinical applications /
Sanford Bolton, Charles Bon.
4th ed., rev. and expanded.
New York : M. Dekker, c2004.
xiii, 755 p. : ill. ; 26 cm. + 1 CD-ROM (4 3/4 in.)
0824746953 (alk. paper)
Computer Disc
More Details
added author
New York : M. Dekker, c2004.
0824746953 (alk. paper)
catalogue key
technical details
Minimum system requirements: Excel workbooks and SAS programs for IBM PC and compatible systems.
Includes bibliographical references and index.
A Look Inside
About the Author
Author Affiliation
Charles Bon is a Biostatistician with AAI Development Services, Wilmington, North Carolina.
This item was reviewed in:
SciTech Book News, December 2003
To find out how to look for other reviews, please see our guides to finding book reviews in the Sciences or Social Sciences and Humanities.
Bowker Data Service Summary
The fourth edition of this text includes a CD-ROM with special programs to aid in problem analysis. The text presents fresh material on concept conformity and release targets and describes linear regression and correlation, the analysis of variance and crossover designs.
Table of Contents
Prefacep. v
Basic Definitions and Conceptsp. 1
Variables and Variationp. 1
Frequency Distributions and Cumulative Frequency Distributionsp. 4
Sample and Populationp. 9
Measures Describing the Center of Data Distributionsp. 12
Measurement of the Spread of Datap. 16
Codingp. 22
Precision, Accuracy, and Biasp. 24
The Question of Significant Figuresp. 27
Data Graphicsp. 31
Introductionp. 31
The Histogramp. 32
Construction and Labeling of Graphsp. 33
Scatter Plots (Correlation Diagrams)p. 40
Semilogarithmic Plotsp. 42
Other Descriptive Figuresp. 43
Introduction to Probability: The Binomial and Normal Probability Distributionsp. 49
Introductionp. 49
Some Basic Probabilityp. 50
Probability Distributions--The Binomial Distributionp. 54
Continuous Data Distributionsp. 63
Other Common Probability Distributionsp. 76
Choosing Samplesp. 82
Introductionp. 82
Random Samplingp. 83
Other Sampling Procedures: Stratified, Systematic, and Cluster Samplingp. 88
Sampling in Quality Controlp. 90
Statistical Inference: Estimation and Hypothesis Testingp. 96
Statistical Estimation (Confidence Intervals)p. 96
Statistical Hypothesis Testingp. 104
Comparison of Variances in Independent Samplesp. 139
Test of Equality of More than Two Variancesp. 141
Confidence Limits for a Variancep. 142
Tolerance Intervalsp. 144
Sample Size and Powerp. 151
Introductionp. 151
Determination of Sample Size for Simple Comparative Experiments for Normally Distributed Variablesp. 153
Determination of Sample Size for Binomial Testsp. 159
Determination of Sample Size to Obtain a Confidence Interval of Specified Widthp. 161
Powerp. 162
Sample Size and Power for More than Two Treatmentsp. 166
Sample Size for Bioequivalence Studiesp. 168
Linear Regression and Correlationp. 173
Introductionp. 174
Analysis of Standard Curves in Drug Analysis: Application of Linear Regressionp. 178
Assumptions in Tests of Hypotheses in Linear Regressionp. 179
Estimate of the Variance: Variance of Sample Estimates of the Parametersp. 181
A Drug Stability Study: A Second Example of the Application of Linear Regressionp. 183
Confidence Intervals in Regression Analysisp. 189
Weighted Regressionp. 193
Analysis of Residualsp. 195
Nonlinear Regressionp. 197
Correlationp. 200
Comparison of Variances in Related Samplesp. 208
Analysis of Variancep. 215
One-Way Analysis of Variancep. 215
Planned Versus a Posteriori (Unplanned) Comparisons in ANOVAp. 222
Another Example of One-Way Analysis of Variance: Unequal Sample Sizes and the Fixed and Random Modelsp. 232
Two-Way Analysis of Variance (Randomized Blocks)p. 234
Statistical Modelsp. 249
Analysis of Covariancep. 250
ANOVA for Pooling Regression Lines as Related to Stability Datap. 256
Factorial Designsp. 265
Definitions (Vocabulary)p. 265
Two Simple Hypothetical Experiments to Illustrate the Advantages of Factorial Designsp. 270
Performing Factorial Experiments: Recommendations and Notationp. 273
A Worked Example of a Factorial Experimentp. 275
Fractional Factorial Designsp. 281
Some General Commentsp. 285
Transformations and Outliersp. 289
Transformationsp. 290
Outliersp. 300
Experimental Design in Clinical Trialsp. 311
Introductionp. 311
Some Principles of Experimental Design and Analysisp. 312
Parallel Designp. 317
Crossover Designs and Bioavailability/Bioequivalence Studiesp. 321
Repeated Measures (Split-Plot) Designsp. 360
Multiclinic Studiesp. 365
Interim Analysesp. 367
Quality Controlp. 373
Introductionp. 373
Control Chartsp. 374
Acceptance Sampling and Operating Characteristic Curvesp. 388
Statistical Procedures in Assay Developmentp. 391
Establishing In-House Limitsp. 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
Validationp. 416
Process Validationp. 416
Assay Validationp. 428
Concluding Remarksp. 435
Computer Intensive Methodsp. 437
Monte Carlo Simulationp. 438
Bootstrappingp. 458
Nonparametric Methodsp. 464
Data Characteristics and an Introduction to Nonparametric Proceduresp. 464
Sign Testp. 467
Wilcoxon Signed Rank Testp. 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 Covariancep. 485
Runs Test for Randomnessp. 486
Contingency Tablesp. 489
Non Parametric Tolerance Intervalp. 500
Optimization Techniques and Screening Designs**p. 506
Introductionp. 506
Optimization Using Factorial Designsp. 508
Composite Designs to Estimate Curvaturep. 518
The Simplex Latticep. 523
Sequential Optimizationp. 531
Glossaryp. 540
Some Properties of the Variancep. 542
Pooling Variancesp. 542
Components of Variancep. 543
Variance of Linear Combinations of Independent Variablesp. 543
Comparison of Slopes and Testing of Linearity: Determination of Relative Potencyp. 545
Multiple Regressionp. 551
Tablesp. 557
Random Numbersp. 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 0.7p. 559
t Distributionsp. 561
Short Table of Chi-Square Distributionsp. 561
Upper 5% Values of the F Distributionp. 562
Short Table of Upper 1% Values of the F Distributionp. 563
Upper 5% Points in the Studentized Rangep. 564
Values of t' for Dunnett's Comparison of Several Treatments and a Control ([alpha] = 0.05)p. 564
Dixon's Criteria for Rejecting Outliersp. 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 Rp. 567
Number of Correct Guesses Needed for Significance in the Triangle Testp. 568
Number of Positive or Negative Signs Needed for Significance for the Sign Testp. 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 Significancep. 569
Probability of Getting at Least One Run of Given Size for N Samplesp. 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 ANOVAp. 571
Critical Differences for Significance ([alpha] = 0.05) Comparing All Possible Pairs of Treatments for Nonparametric Two-Way ANOVAp. 572
Factors for Two-Sided Tolerance Limits for Normal Distributionsp. 573
Test for Outliersp. 576
Outlier Tests and Chemical Assaysp. 578
Introductionp. 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 Assaysp. 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 Decisionp. 594
Excel Workbooks and SAS Programsp. 599
Excel Workbooksp. 599
SAS Programsp. 653
An Alternative Solution to the Distribution of the Individual Bioequivalence Metricp. 711
Answers to Exercisesp. 722
Indexp. 743
Table of Contents provided by Ingram. All Rights Reserved.

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