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(Ebook) Pharmaceutical Statistics Practical and Clinical Applications 4th Edition by Sanford Bolton, Charles Bon ISBN 0824746953 9780824746957

  • SKU: EBN-5694584
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Instant download (eBook) Pharmaceutical Statistics: Practical and Clinical Applications, Revised and Expanded after payment.
Authors:Sanford Bolton, Charles Bon
Pages:776 pages.
Year:2003
Editon:4
Publisher:CRC Press
Language:english
File Size:12.84 MB
Format:pdf
ISBNS:9780824746957, 0824746953
Categories: Ebooks

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(Ebook) Pharmaceutical Statistics Practical and Clinical Applications 4th Edition by Sanford Bolton, Charles Bon ISBN 0824746953 9780824746957

(Ebook) Pharmaceutical Statistics Practical and Clinical Applications 4th Edition by Sanford Bolton, Charles Bon - Ebook PDF Instant Download/Delivery: 0824746953, 9780824746957
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ISBN 10: 0824746953 
ISBN 13: 9780824746957
Author: Sanford Bolton, Charles Bon

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.

(Ebook) Pharmaceutical Statistics Practical and Clinical Applications 4th Table of contents:

1 Basic Definitions and Concepts
1.1 Variables and Variation
1.1.1 Continuous Variables
1.1.2 Discrete Variables
1.2 Frequency Distributions and Cumulative Frequency Distributions
1.2.1 Frequency Distributions
1.2.2 Stem-and-Leaf Plot
1.2.3 Cumulative Frequency Distributions
1.3 Sample and Population
1.3.1 Population Parameters and Sample Statistics
1.4 Measures Describing the Center of Data Distributions
1.4.1 The Average
1.4.2 Other Kinds of Averages
1.4.3 The Median
1.5 Measurement of the Spread of Data
1.5.1 Range
1.5.2 Standard Deviation and Variance
1.5.3 Coefficient of Variation
1.5.4 Standard Deviation of the Mean (Standard Error of the Mean)
1.5.5 Variance of a Weighted Average‡‡
1.6 Coding
1.7 Precision, Accuracy, and Bias
1.7.1 Precision
1.7.2 Accuracy
1.7.3 Bias
1.8 The Question of Significant Figures
Key Terms
Exercises
References
2 DATA GRAPHICS
2.1 Introduction
2.2 The Histogram
2.3 Construction and Labeling of Graphs
2.4 Scatter Plots (Correlation Diagrams)
2.5 Semilogarithmic Plots
2.6 Other Descriptive Figures
Key Terms
Exercises
References
3 Introduction to Probability: The Binomial and Normal Probability Distributions
3.1 Introduction
3.2 Some Basic Probability
3.2.1 Some Elementary Definitions and Theorems
3.2.2 Independent Events
3.3 Probability Distributions—the Binomial Distribution
3.3.1 Some Definitions
3.3.2 Summary of Properties of the Binomial Distribution
3.3.3 Confidence Limits with N Observations and Zero Successes or Failures
3.3.4 The Negative Binomial Distribution [5,6]
3.4 Continuous Data Distributions
3.4.1 The Normal Distribution
3.4.2 Central Limit Theorem
3.4.3 Normal Approximation to the Binomial
3.5 Other Common Probability Distributions
3.5.1 The Poisson Distribution
3.5.2 The t Distribution (“Student’s t”)
3.5.3 The Chi-Square (x2) Distribution
3.5.4 The F Distribution
3.6 The Log-Normal Distribution
3.6.1 Statistical Analysis of Particle Size
Key Terms
Exercises
References
4 Choosing Samples
4.1 Introduction
4.2 Random Sampling
4.2.1 Table of Random Numbers
4.3 Other Sampling Procedures: Stratified, Systematic, and Cluster Sampling
4.3.1 Stratified Sampling
4.3.2 Systematic Sampling
4.3.3 Cluster Sampling
4.4 Sampling in Quality Control
Key Terms
Exercises
References
5 Statistical Inference: Estimation and Hypothesis Testing
5.1 Statistical Estimation (Confidence Intervals)
5.1.1 Confidence Intervals Using the t Distribution
5.1.2 Examples of Construction of Confidence Intervals
5.1.3 Asymmetric Confidence Intervals
5.1.3.1 One-SidedConfidenceIntervals
5.1.3.2 OtherAsymmetricConfidenceIntervals
5.2 Statistical Hypothesis Testing
5.2.1 Case I: Test of the Mean from a Single Population (One-Sample Tests), an Introduction to a Simple Example of Hypothesis Testing
5.2.2 Case II: Comparisons of Means from Two Independent Groups (Two Independent Groups Test)
5.2.2.1 TwoIndependent-GroupsTest,VariancesKnown
5.2.2.2 Two-Independent-GroupsTest,VarianceUnknown
5.2.2.3 ConfidenceIntervalfortheDifferenceofTwoMeans
5.2.2.4 TestofSignificanceIfVariancesoftheTwoGroupsAreUnequal
5.2.2.5 OverlappingConfidenceIntervalsandStatisticalSignificance
5.2.2.6 Summaryoft-TestProcedureandDesignforComparisonofTwoIndependentGroups
5.2.3 Test for Comparison of Means of Related Samples (Paired-Sample t Test)
5.2.4 Normal Distribution Tests for Proportions (Binomial Tests)
5.2.4.1 TesttoComparetheProportionofaSampletoaKnownorHypotheticalProportion
5.2.4.2 TestsfortheComparisonofProportionsfromTwoIndependentGroups
5.2.5 Chi-Square Tests for Proportions
5.2.6 Confidence Intervals for Proportions
5.3 Comparison of Variances in Independent Samples
5.4 Test of Equality of More Than Two Variances
5.5 Confidence Limits for A Variance
5.5.1 Rationale for USP Content Uniformity Test
5.6 Tolerance Intervals
Key Terms
Exercises
References
6 Sample Size and Power
6.1 Introduction
6.2 Determination of Sample Size for Simple Comparative Experiments for Normally Distributed Variables
6.2.1 Paired-Sample and Single-Sample Tests
6.2.2 Determination of Sample Size for Comparison of Means in Two Groups
6.3 Determination of Sample Size for Binomial Tests
6.4 Determination of Sample Size To Obtain A Confidence Interval of Specified Width
6.5 Power
6.6 Sample Size and Power for More Than Two Treatments (Also See Chap. 8)
6.7 Sample Size for Bioequivalence Studies (Also See Chap. 11)
Key Terms
Exercises
References
7 Linear Regression and Correlation
7.1 Introduction
7.2 Analysis of Standard Curves in Drug Analysis: Application of Linear Regression
7.2.1 Line Through the Origin
7.3 Assumptions in Tests of Hypotheses in Linear Regression
7.4 Estimate of the Variance: Variance of Sample Estimates of the Parameters
7.4.1 Test of the Intercept, A
7.4.2 Test of the Slope, B
7.5 A Drug Stability Study: A Second Example of the Application of Linear Regression
7.6 Confidence Intervals in Regression Analysis
7.6.1 Confidence Interval for Y at a Given X
7.6.2 A Confidence Interval for X at a Given Value of Y
7.6.3 Prediction Intervals
7.6.4 Confidence Intervals for Slope (B) and Intercept (A)
7.7 Weighted Regression
7.8 Analysis of Residuals
7.9 Nonlinear Regression**
7.10 Correlation
7.10.1 Correlation Coefficient
7.10.2 Test of Zero Correlation
7.10.3 Miscellaneous Comments
7.11 Comparison of Variances in Related Samples
Key Terms
Exercises
References
8 Analysis of Variance
8.1 One-Way Anova
8.1.1 Computations and Procedure for One-Way ANOVA
8.1.1.1 Testing the Hypothesis of Equal Treatment Means
8.1.2 Summary of Procedure for One-Way ANOVA
8.1.3 A Common But Incorrect Analysis of the Comparison of Means from More Than Two Groups
8.2 Planned Versus A Posteriori (Unplanned) Comparisons in Anova
8.2.1 Multiple Comparisons in ANOVA
8.2.1.1 Least Significant Difference
8.2.1.2 Tukey’s Multiple Range Test
8.2.1.3 Scheffé Method
8.2.1.4 Newman–Keuls Test
8.2.1.5 Dunnett’s Test
8.2.2 Multiple Correlated Outcomes§
8.3 Another Example of One-Way Anova: Unequal Sample Sizes and the Fixed and Random Models
8.3.1 Fixed and Random Models
8.4 Two-Way Anova (Randomized Blocks)
8.4.1 A Comparison of Dissolution of Various Tablet Formulations: Random and Fixed Models in Two-Way ANOVA
8.4.1.1 Tests of Significance
8.4.1.2 Fixed and Random Effects in the Two-Way Model §
8.4.2 Two-Way ANOVA with Replication
8.4.3 Another Worked Example of Two-Way ANOVA§
8.4.3.1 Conclusions of the Experiment Comparing Three Treatments at Three Sites: Interpretation of the ANOVA Table
8.4.4 Missing Data
8.5 Statistical Models§
8.6 Analysis of Covariance§
8.6.1 Comparison of ANCOVA with Other Analyses
8.7 Anova for Pooling Regression Lines As Related To Stability Data§
Key Terms
Exercises
References
9 Factorial Designs
9.1 Definitions (Vocabulary)
9.1.1 Factor
9.1.2 Levels
9.1.3 Effects
9.1.4 Interaction
9.2 Two Simple Hypothetical Experiments To Illustrate the Advantages of Factorial Designs
9.3 Performing Factorial Experiments: Recommendations and Notation
9.4 A Worked Example of A Factorial Experiment
9.4.1 Data Analysis
9.4.1.1 MethodofYates
9.4.1.2 Analysis of Variance
9.4.1.3 Interpretation
9.5 Fractional Factorial Designs
9.6 Some General Comments
Key Terms
Exercises
References
10 Transformations and Outliers
10.1 Transformations
10.1.1 The Logarithmic Transformation
10.1.1.1 Analysis of Residuals
10.1.2 The Arcsin Transformation for Proportions
10.1.3 Other Transformations
10.2 Outliers
10.2.1 Dixon’s Test for Extreme Values
10.2.2 The T Procedure
10.2.3 Winsorizing
10.2.4 Overall View and Examples of Handling Outliers
10.2.4.1 Lund’s Method
Key Terms
Exercises
References
11 Experimental Design in Clinical Trials
11.1 Introduction
11.2 Some Principles of Experimental Design and Analysis
11.2.1 Absence of Bias
11.2.2 Absence of Systematic Errors
11.2.3 Adequate Precision
11.2.4 Choice of Patients
11.2.5 Simplicity and Symmetry
11.2.6 Randomization
11.2.7 Intent to Treat
11.3 Parallel Design
11.3.1 ANOVA Using Only Post-Treatment Results
11.3.2 ANOVA of Differences from the Baseline
11.4 Crossover Designs and Bioavailability/Bioequivalence Studies
11.4.1 Description of Crossover Designs: Advantages and Disadvantages
11.4.2 Bioavailability/Bioequivalence Studies†
11.4.2.1 Statistical Analysis
11.4.2.2 Test for Carryover Effects
11.4.3 Confidence Intervals in BE Studies
11.4.3.1 Locke’s Method of Analysis (Confidence Interval for the Ratio of Two Normally Distributed Variables)
11.4.3.2 Nontransformed Data
11.4.3.3 Log-Transformed Data (Current Procedure)
11.4.4 Sample Size and Highly Variable Drug Products
11.4.5 Outliers in BE Studies
11.4.6 Replicate Designs for BE Studies**
11.4.6.1 Individual Bioequivalence††
11.4.6.2 Constant Scaling
11.4.6.3 Statistical Analysis for IB
11.4.6.4 The Future
11.4.7 Sample Size for Test for Equivalence for a Dichotomous (Pass–Fail) Outcome
11.4.8 SCALED CRITERION FOR BE
11.4.9 NONINFERIORITY TRIALS
11.5 Repeated Measures (Split-Plot) Designs
11.5.1 Experimental Design
11.5.2 ANOVA
11.5.2.1 Interpretation and Discussion
11.6 Multiclinic Studies
11.7 Interim Analyses
Key Terms
Exercises
References
12 Quality Control
12.1 Introduction
12.2 Control Charts
12.2.1 Statistical Control
12.2.2 Constructing Control Charts
12.2.2.1 RationalSubgroups
12.2.2.2 EstablishingControlChartLimits
12.2.3 Between-Batch Variation as a Measure of Variability (Moving Averages)
12.2.4 Quality Control Charts in Research and Development
12.2.5 Control Charts for Proportions
12.2.6 Runs in Control Charts
12.3 Acceptance Sampling and Operating Characteristic Curves
12.4 Statistical Procedures in Assay Development
12.4.1 Components of Variance‡
12.4.1.1 Nested Designs
12.5 Establishing in-House Limits
12.6 Some Statistical Aspects of Quality and the “Barr Decision”
12.7 Important Qc Tests for Finished Solid Dosage Forms (Tablets and Capsules)
12.7.1 Content Uniformity
12.7.2 Assay
12.7.3 Dissolution
12.8 Out of Specification (Oos) Results
Key Terms
Exercises
References
13 Validation
13.1 Process Validation
13.1.1 Retrospective Validation
13.1.2 Prospective Validation
13.1.3 Sampling in Process Validation
13.2 Assay Validation
13.3 Concluding Remarks
Key Terms
Exercises
References
14 Computer-Intensive Methods
14.1 Monte Carlo Simulation
14.2 Bootstrapping
References
15 Nonparametric Methods
15.1 Data Characteristics and An Introduction To Nonparametric Procedures
15.2 Sign Test
15.3 Wilcoxon Signed Rank Test
15.3.1 Nonparametric Confidence Intervals for Crossover Studies and Bioequivalence
15.4 Wilcoxon Rank Sum Test (Test for Differences Between Two Independent Groups)
15.4.1 Nonparametric Analysis of Two-Way Crossover (Bioequivalence Designs)
15.5 Kruskal-Wallis Test (One-Way Anova)
15.6 Friedman Test (Two-Way Analysis of Variance)
15.6.1 Modified Friedman Test
15.6.1.1 MultipleComparisonsfortheModifiedFriedmanTest
15.6.2 Quade Test for Randomized Block Design
15.7 Nonparametric Analysis of Covariance
15.8 Runs Test for Randomness
15.9 Contingency Tables
15.9.1 R × C Tables
15.9.2 Fisher’s Exact Test
15.9.3 Fourfold Tables with Related Samples
15.9.4 Analysis of Combined Sets of 2 × 2 Tables
15.9.5 Randomized Blocks with Binomial Outcome
15.10 Nonparametric Tolerance Interval
Key Terms
Exercises
References
16 Optimization Techniques and Screening Designs*
16.1 Introduction
16.1.1 Planning Experiments
16.1.2 Variables
16.1.3 Variability or Experimental Error
16.1.4 Regression
16.2 Optimization Using Factorial Designs
16.2.1 Replication (Sample Size)
Example:
16.2.2 Extra (Center) Points
16.2.3 Optimization of a Combination Drug Product
16.3 Composite Designs To Estimate Curvature
16.4 The Simplex Lattice [12]
16.5 Sequential Optimization**
16.5.1 An Example of Sequential Simplex Optimization
16.6 Screening Designs

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