Pharmaceutical Statistics Using SAS: A Practical Guide

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SAS Institute, 2007 - Computers - 464 pages
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Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
 

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Contents

82 Bioequivalence Testing
199
83 Assessing Dose Linearity
204
References
209
Allocation in Randomized Clinical Trails 91 Introduction
213
92 Permuted Block Randomization
214
93 Variations of Permuted Block Randomization
217
94 Allocations Balanced on Baseline Covariates
228
Acknowledgments References
233

23 Boosting
10
24 Model Building
27
25 Partial Least Squares for Discrimination
33
References
42
Model Building Techniques in Drug Discovery 31 Introduction
45
Solubility Data
46
33 Training and Test Set Selection
47
34 Variable Selection
51
35 Statistical Procedures for Model Building
58
36 Determining When a New Observation Is Not in a Training Set
61
37 Using SAS Enterprise Miner
63
References
67
Statistical Considerations in Analytical Method Validation 41 Introduction
69
42 Validation Criteria
73
43 Response Function or Calibration Curve
74
44 Linearity
83
45 Accuracy and Precision
85
46 Decision Rule
88
47 Limits of Quantification and Range of the Assay
92
49 Summary
93
References
94
Some Statistical Considerations in Nonclinical Safety Assessment 51 Overview of Nonclinical Safety Assessment
97
52 Key Statistical Aspects of Toxicology Studies
98
53 Randomization in Toxicology Studies
99
54 Power Evaluation in a TwoFactor Model for QT Interval
102
55 Statistical Analysis of a OneFactor Design with Repeated Measures
106
56 Summary
113
References
115
Nonparametric Methods in Pharmaceutical Statistics 61 Introduction
117
62 Two Independent Samples Setting
118
63 The OneWay Layout
129
64 Power Determination in a Purely Nonparametric Sense
144
References
149
Optimal Design of Experiments in Pharmaceutical Applications
151
71 Optimal Design Problem
152
72 Quantal DoseResponse Models
159
73 Nonlinear Regression Models with a Continuous Response
165
74 Regression Models with Unknown Parameters in the Variance Function
169
75 Models with a Bounded Response Beta Models
172
76 Models with a Bounded Response Logit Link
176
77 Bivariate Probit Models for Correlated Binary Responses
181
78 Pharmacokinetic Models with Multiple Measurements per Patient
184
79 Models with Cost Constraints
190
710 Summary
192
References
193
Analysis of Human Pharmacokinetic Data 81 Introduction
197
SampleSize Analysis for Traditional Hypothesis Testing Concepts and Issues
237
101 Introduction
238
Does QCA Decrease Mortality in Children with Severe Malaria?
240
103 pValues α β and Power
241
104 A Classical Power Analysis
243
Crucial Type I and Type II Error Rates
249
Crucial Error Rates for Mortality Analysis
251
Does QCA Affect the Elysemine Elysemate Ratios EER?
253
108 Crucial Error Rates When the Null Hypothesis Is Likely to Be True
262
1010 Summary
263
References Appendix A Guidelines for Statistical Considerations Sections
264
Appendix B SAS Macro Code to Automate the Programming
265
Design and Analysis of DoseRanging Clinical Studies 111 Introduction
273
112 Design Considerations
277
113 Detection of DoseResponse TrendsSJ
280
114 Regression Modeling
289
115 DoseFinding Procedures
294
116 Summary
309
References
310
Analysis of Incompete Date
313
121 Introduction
314
122 Case Studies
316
123 Data Setting and Modeling Framework
318
124 Simple Methods and MCAR
319
125 MAR Methods
320
126 Categorical Data
322
127 MNAR Modeling
340
128 Sensitivity Analysis
347
References
356
Reliability and Validity Assessing the Psychometric Properties of Rating Scales 131 Introduction
361
132 Reliability
362
133 Validity and Other Topics
376
134 Summary
382
References
383
Decision Analysis in Drug Development 141 Introduction
385
Stop or Go?
386
143 The Structure of a Decision Analysis
392
144 The GoNo Go Problem Revisited
394
145 Optimal Sample Size
397
146 Sequential Designs in Clinical Trials
406
147 Selection of an Optimal Dose
412
148 Project Prioritization
421
Acknowledgments References
426
Index
429
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