Pharmaceutical statistics: practical and clinical applications
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York [u.a.]
Dekker
2004
|
| Edition: | 4. ed., rev. and expanded |
| Series: | Drugs and the pharmaceutical sciences
135 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XIII, 755 S. Ill., graph. Darst. CD-ROM (12 cm) |
| ISBN: | 0824746953 |
Staff View
MARC
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| 250 | |a 4. ed., rev. and expanded | ||
| 264 | 1 | |a New York [u.a.] |b Dekker |c 2004 | |
| 300 | |a XIII, 755 S. |b Ill., graph. Darst. |e CD-ROM (12 cm) | ||
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| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 135 | |
| 500 | |a Includes bibliographical references and index | ||
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| 650 | 4 | |a Pharmacy |x Statistical methods | |
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Record in the Search Index
| _version_ | 1804130383866888192 |
|---|---|
| adam_text | CONTENTS
Preface v
1. Basic Definitions and Concepts 1
1.1 Variables and Variation 1
1.2 Frequency Distributions and Cumulative Frequency Distributions 4
1.3 Sample and Population 9
1.4 Measures Describing the Center of Data Distributions 12
1.5 Measurement of the Spread of Data 16
1.6 Coding 22
1.7 Precision, Accuracy, and Bias 24
1.8 The Question of Significant Figures 27
Key Terms 28
Exercises 28
References 30
2. Data Graphics 31
2.1 Introduction 31
2.2 The Histogram 32
2.3 Construction and Labeling of Graphs 33
2.4 Scatter Plots (Correlation Diagrams) 40
2.5 Semilogarithmic Plots 42
2.6 Other Descriptive Figures 43
Key Terms 46
Exercises 46
References 48
3. Introduction to Probability: The Binomial and Normal Probability
Distributions 49
3.1 Introduction 49
3.2 Some Basic Probability 50
vii
Vjjj Contents
3.3 Probability Distributions—The Binomial Distribution 54
3.4 Continuous Data Distributions 63
3.5 Other Common Probability Distributions 76
Key Terms 79
Exercises 80
References 81
4. Choosing Samples 82
4.1 Introduction 82
4.2 Random Sampling 83
4.3 Other Sampling Procedures: Stratified, Systematic, and Cluster
Sampling 88
4.4 Sampling in Quality Control 90
Key Terms 92
Exercises 92
References 95
5. Statistical Inference: Estimation and Hypothesis Testing 96
5.1 Statistical Estimation (Confidence Intervals) 96
5.2 Statistical Hypothesis Testing 104
5.3 Comparison of Variances in Independent Samples 139
5.4 Test of Equality of More than Two Variances 141
5.5 Confidence Limits for a Variance 142
5.6 Tolerance Intervals 144
Key Terms 146
Exercises 146
References 149
6. Sample Size and Power 151
6.1 Introduction , 151
6.2 Determination of Sample Size for Simple Comparative Experiments
for Normally Distributed Variables 153
6.3 Determination of Sample Size for Binomial Tests 159
6.4 Determination of Sample Size to Obtain a Confidence Interval of
Specified Width 161
6.5 Power 162
6.6 Sample Size and Power for More than Two Treatments 166
6.7 Sample Size for Bioequivalence Studies 168
Key Terms 170
Exercises 170
References 172
7. Linear Regression and Correlation 173
7.1 Introduction 174
7.2 Analysis of Standard Curves in Drug Analysis: Application of Linear
Regression 178
7.3 Assumptions in Tests of Hypotheses in Linear Regression 179
Contents ix
7.4 Estimate of the Variance: Variance of Sample Estimates of the
Parameters 181
7.5 A Drug Stability Study: A Second Example of the Application of
Linear Regression 183
7.6 Confidence Intervals in Regression Analysis 189
7.7 Weighted Regression 193
7.8 Analysis of Residuals 195
7.9 Nonlinear Regression 197
7.10 Correlation 200
7.11 Comparison of Variances in Related Samples 208
Key Terms 210
Exercises 210
References 214
8. Analysis of Variance 215
8.1 One Way Analysis of Variance 215
8.2 Planned Versus a Posteriori (Unplanned) Comparisons in ANOVA 222
8.3 Another Example of One Way Analysis of Variance: Unequal Sample
Sizes and the Fixed and Random Models 232
8.4 Two Way Analysis of Variance (Randomized Blocks) 234
8.5 Statistical Models** 249
8.6 Analysis of Covariance** 250
8.7 ANOVA for Pooling Regression Lines as Related to Stability Data 256
Key Terms 260
Exercises 261
References 264
9. Factorial Designs** 265
9.1 Definitions (Vocabulary) 265
9.2 Two Simple Hypothetical Experiments to Illustrate the Advantages of
Factorial Designs 270
9.3 Performing Factorial Experiments: Recommendations and Notation 273
9.4 A Worked Example of a Factorial Experiment 275
9.5 Fractional Factorial Designs 281
9.6 Some General Comments 285
Key Terms 285
Exercises 285
References 288
10. Transformations and Outliers 289
10.1 Transformations 290
10.2 Outliers 300
Key Terms 309
Exercises 309
References 310
** A more advanced topic.
x Contents
11. Experimental Design in Clinical Trials 311
11.1 Introduction 311
11.2 Some Principles of Experimental Design and Analysis 312
11.3 Parallel Design 317
11.4 Crossover Designs and Bioavailability/Bioequivalence Studies 321
11.5 Repeated Measures (Split Plot) Designs** 360
11.6 Multiclinic Studies 365
11.7 Interim Analyses 367
Key Terms 369
Exercises 369
References 371
12. Quality Control 373
12.1 Introduction 373
12.2 Control Charts 374
12.3 Acceptance Sampling and Operating Characteristic Curves 388
12.4 Statistical Procedures in Assay Development 391
12.5 Establishing In House Limits 401
12.6 Some Statistical Aspects of Quality and the Barr Decision 404
12.7 Important QC Tests for Finished Solid Dosage Forms (Tablets and
Capsules) 408
12.8 Out of Specification (00S) Results
Key Terms 412
Exercises 413
References 415
13. Validation 416
13.1 Process Validation 416
13.2 Assay Validation 428
13.3 Concluding Remarks 435
Key Terms 435
Exercises 435
References 436
14. Computer Intensive Methods 437
14.1 Monte Carlo Simulation 438
14.2 Bootstrapping 458
References 463
15. Nonparametric Methods 464
15.1 Data Characteristics and an Introduction to Nonparametric
Procedures 464
15.2 Sign Test 467
15.3 Wilcoxon Signed Rank Test 469
** A more advanced topic.
Contents xi
15.4 Wilcoxon Rank Sum Test (Test for Differences Between Two
Independent Groups) 473
15.5 Kruskal Wallis Test (One Way ANOVA) 479
15.6 Friedman Test (Two Way Analysis of Variance) 481
15.7 Nonparametric Analysis of Covariance 485
15.8 Runs Test for Randomness 486
15.9 Contingency Tables 489
15.10 Non Parametric Tolerance Interval 500
Key Terms 501
Exercises 501
References 505
16. Optimization Techniques and Screening Designs** 506
16.1 Introduction 506
16.2 Optimization Using Factorial Designs 508
16.3 Composite Designs to Estimate Curvature 518
16.4 The Simplex Lattice 523
16.5 Sequential Optimization 531
Key Terms 537
Exercises 537
References 538
Glossary 540
Appendix I: Some Properties of the Variance 542
1.1 Pooling Variances 542
1.2 Components of Variance 543
1.3 Variance of Linear Combinations of Independent Variables 543
Reference 544
Appendix II: Comparison of Slopes and Testing of Linearity:
Determination of Relative Potency 545
Reference 550
Appendix III: Multiple Regression 551
References 556
Appendix IV: Tables 557
IV. 1 Random Numbers 557
IV.2 Cumulative Normal Distribution Cumulative Area Under the
Normal Distribution (Less Than or Equal to Z) 558
IV.3 Individual Terms of the Binomial Distribution for N = 2 to 10 and
P = 0.2, 0.5, and 0.7 559
IV.4 t Distributions 561
IV.5 Short Table of Chi Square Distributions 561
IV.6A Upper 5% Values of the F Distribution 562
IV.6B Short Table of Upper 1% Values of the F Distribution 563
IV.7A Upper 5% Points in the Studentized Range 564
xij Contents
IV.7B Values of t for Dunnett s Comparison of Several Treatments and a
Control (a = 0.05) 564
IV.8 Dixon s Criteria for Rejecting Outliers 565
IV.9 Critical Values of T for a Two Sided Test at the 5% Level of
Significance (Test for Outliers) 566
IV. 10 Factors for Determining Upper and Lower 3ct Limits for Mean (X)
and Range (/?) Charts, and for Estimating a from R 567
IV. 11 Number of Correct Guesses Needed for Significance in the
Triangle Test 568
IV. 12 Number of Positive or Negative Signs Needed for Significance for
the Sign Test 568
IV. 13 Values Leading to Significance for the Wilcoxon Signed Rank Test
(Two Sided Test) 569
IV. 14 Critical Values for Number of Runs at the 5% Level of
Significance 569
IV. 15 Probability of Getting at Least One Run of Given Size for N
Samples 570
IV. 16 Critical Values for Wilcoxon Rank Sum Test (a = 0.05) 570
IV. 17 Critical Differences for Significance (a = 0.05) Comparing All
Possible Pairs of Treatments for Nonparametric One Way
ANOVA 571
IV. 18 Critical Differences for Significance (a = 0.05) Comparing All
Possible Pairs of Treatments for Nonparametric Two Way
ANOVA 572
IV. 19 Factors for Two Sided Tolerance Limits for Normal Distributions 573
IV.20 Test for Outliers 576
Appendix V: Outlier Tests and Chemical Assays 578
V.I Introduction 578
V.2 Can Outlier Tests Be Justified? 579
V.3 Why Is There Not a USP Test for Outliers for Chemical Assays? 580
V.4 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 581
V.5 What Is the Purpose of Performing Replicate Assays and When is
Averaging Appropriate? 582
V.6 In What Situations Might Outlier Tests Be Applicable? 582
References 584
Appendix VI: Should a Single Unexplained Failing Assay Be Reason to
Reject a Batch? 585
References 593
Appendix VII: When it is Appropriate to Average and its Relationship to
the Barr Decision 594
Contents xiii
Appendix VIII: Excel Workbooks and SAS Programs 599
Excel Workbooks 599
SAS Programs 653
Appendix IX: An Alternative Solution to the Distribution of the Individual
Bioequivalence Metric 711
Answers to Exercises 722
Index 743
|
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| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.1/072 |
| dewey-search | 615/.1/072 |
| dewey-sort | 3615 11 272 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| edition | 4. ed., rev. and expanded |
| format | Book |
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| id | DE-604.BV017635681 |
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| indexdate | 2024-07-09T19:20:10Z |
| institution | BVB |
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| language | English |
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| physical | XIII, 755 S. Ill., graph. Darst. CD-ROM (12 cm) |
| publishDate | 2004 |
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| publisher | Dekker |
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| series | Drugs and the pharmaceutical sciences |
| series2 | Drugs and the pharmaceutical sciences |
| spelling | Bolton, Sanford Verfasser aut Pharmaceutical statistics practical and clinical applications Sanford Bolton ; Charles Bon 4. ed., rev. and expanded New York [u.a.] Dekker 2004 XIII, 755 S. Ill., graph. Darst. CD-ROM (12 cm) txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 135 Includes bibliographical references and index Pharmacy Laboratory Manuals Pharmacy Statistical methods Statistics as Topic Laboratory Manuals Methode (DE-588)4038971-6 gnd rswk-swf Pharmazie (DE-588)4045705-9 gnd rswk-swf Statistik (DE-588)4056995-0 gnd rswk-swf Pharmazie (DE-588)4045705-9 s Statistik (DE-588)4056995-0 s Methode (DE-588)4038971-6 s DE-604 Bon, Charles 1949- Verfasser (DE-588)173782728 aut Drugs and the pharmaceutical sciences 135 (DE-604)BV000002008 135 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010607009&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Bolton, Sanford Bon, Charles 1949- Pharmaceutical statistics practical and clinical applications Drugs and the pharmaceutical sciences Pharmacy Laboratory Manuals Pharmacy Statistical methods Statistics as Topic Laboratory Manuals Methode (DE-588)4038971-6 gnd Pharmazie (DE-588)4045705-9 gnd Statistik (DE-588)4056995-0 gnd |
| subject_GND | (DE-588)4038971-6 (DE-588)4045705-9 (DE-588)4056995-0 |
| title | Pharmaceutical statistics practical and clinical applications |
| title_auth | Pharmaceutical statistics practical and clinical applications |
| title_exact_search | Pharmaceutical statistics practical and clinical applications |
| title_full | Pharmaceutical statistics practical and clinical applications Sanford Bolton ; Charles Bon |
| title_fullStr | Pharmaceutical statistics practical and clinical applications Sanford Bolton ; Charles Bon |
| title_full_unstemmed | Pharmaceutical statistics practical and clinical applications Sanford Bolton ; Charles Bon |
| title_short | Pharmaceutical statistics |
| title_sort | pharmaceutical statistics practical and clinical applications |
| title_sub | practical and clinical applications |
| topic | Pharmacy Laboratory Manuals Pharmacy Statistical methods Statistics as Topic Laboratory Manuals Methode (DE-588)4038971-6 gnd Pharmazie (DE-588)4045705-9 gnd Statistik (DE-588)4056995-0 gnd |
| topic_facet | Pharmacy Laboratory Manuals Pharmacy Statistical methods Statistics as Topic Laboratory Manuals Methode Pharmazie Statistik |
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