Design and analysis of cross-over trials:
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| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Boca Raton, FL [u.a.]
Chapman & Hall/CRC
2003
|
| Edition: | 2. ed. |
| Series: | Monographs on statistics and applied probability
98 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Literaturverz. S. 359 - 376 |
| Physical Description: | XXV, 382 S. graph. Darst. |
| ISBN: | 0412606402 |
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MARC
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Record in the Search Index
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| adam_text | Contents
Preface xiii
List of figures xvii
List of tables xix
1 Introduction 1
1.1 What is a cross over trial? 1
1.2 With which sort of cross over trial are we concerned? 2
1.3 Why do cross over trials need special consideration? 3
1.4 A brief history 5
1.5 Notation, models and analysis 7
1.6 Aims of this book 10
1.7 Structure of the book 11
2 The 2x2 cross over trial 13
2.1 Introduction 13
2.2 Plotting the data 14
2.3 The analysis using i tests 21
2.4 Sample size calculations 30
2.5 The analysis of variance 37
2.6 Aliasing of effects 42
2.7 Consequences of preliminary testing 44
2.8 Analyzing the1 residuals 50
2.9 A Bayesian analysis of the 2x2 trial 54
2.10 The use of baseline measurements 01
2.11 The use of covariates 70
2.12 Xonparametrie analysis 7G
2.13 Binary data 106
3 Higher order designs for two treatments 117
3.1 Introduction 117
3.2 Optimal designs US
3.3 Balaam s design for two treatments 119
x CONTENTS
3.4 Preliminary testing in Balaam s design 123
3.5 Three period designs with two sequences 126
3.6 Three period designs with four sequences 131
3.7 A three period six sequence design 135
3.8 Which three period design to use? 136
3.9 Four period designs with two sequences 138
3.10 Four period designs with four sequences 141
3.11 Four period designs with six sequences 143
3.12 Which four period design to use? 144
3.13 Which two treatment design to use? 146
4 Designs for three or more treatments 151
4.1 Introduction 151
4.2 Variance balanced designs 154
4.3 Optimality results for cross over designs 177
4.4 Which variance balanced design to use? 180
4.5 Partially balanced designs 181
4.6 Comparing test treatments to a control 190
4.7 Factorial treatment combinations 191
4.8 Extending the simple model for carry over effects 198
4.9 Computer search algorithms 199
5 Analysis of continuous data 205
5.1 Introduction 205
5.2 The fixed subject effects model 206
5.3 The random subject effects model 213
5.4 Analyses for higher order two treatment designs 225
5.5 The general linear mixed model 234
5.6 Analysis of repeated measurements within periods 235
5.7 Cross over data as repeated measurements 246
5.8 Case study: an analysis of a trial with many periods 263
6 Analysis of categorical data 281
6.1 Introduction 281
6.2 Binary data: subject effect models 286
6.3 Binary data: marginal models 303
6.4 Categorical data 308
6.5 Further topics 318
7 Bioequivalence trials 323
7.1 What is bioequivalence? 323
7.2 Testing for average bioequivalence 327
7.3 Power and sample size for ABE in the 2x2 design 336
CONTENTS xi
7.4 Individual bioequivalence 337
7.5 Population bioequivalence 343
7.6 ABE for a replicate design 345
7.7 Kullback Leibler divergence 346
7.8 Modelling pharmacokinetic data 347
A Least squares estimation 351
B SAS code for assessing ABE, IBE and PBE 355
References 359
Index 377
|
| adam_txt |
Contents
Preface xiii
List of figures xvii
List of tables xix
1 Introduction 1
1.1 What is a cross over trial? 1
1.2 With which sort of cross over trial are we concerned? 2
1.3 Why do cross over trials need special consideration? 3
1.4 A brief history 5
1.5 Notation, models and analysis 7
1.6 Aims of this book 10
1.7 Structure of the book 11
2 The 2x2 cross over trial 13
2.1 Introduction 13
2.2 Plotting the data 14
2.3 The analysis using i tests 21
2.4 Sample size calculations 30
2.5 The analysis of variance 37
2.6 Aliasing of effects 42
2.7 Consequences of preliminary testing 44
2.8 Analyzing the1 residuals 50
2.9 A Bayesian analysis of the 2x2 trial 54
2.10 The use of baseline measurements 01
2.11 The use of covariates 70
2.12 Xonparametrie analysis 7G
2.13 Binary data 106
3 Higher order designs for two treatments 117
3.1 Introduction 117
3.2 Optimal' designs US
3.3 Balaam's design for two treatments 119
x CONTENTS
3.4 Preliminary testing in Balaam's design 123
3.5 Three period designs with two sequences 126
3.6 Three period designs with four sequences 131
3.7 A three period six sequence design 135
3.8 Which three period design to use? 136
3.9 Four period designs with two sequences 138
3.10 Four period designs with four sequences 141
3.11 Four period designs with six sequences 143
3.12 Which four period design to use? 144
3.13 Which two treatment design to use? 146
4 Designs for three or more treatments 151
4.1 Introduction 151
4.2 Variance balanced designs 154
4.3 Optimality results for cross over designs 177
4.4 Which variance balanced design to use? 180
4.5 Partially balanced designs 181
4.6 Comparing test treatments to a control 190
4.7 Factorial treatment combinations 191
4.8 Extending the simple model for carry over effects 198
4.9 Computer search algorithms 199
5 Analysis of continuous data 205
5.1 Introduction 205
5.2 The fixed subject effects model 206
5.3 The random subject effects model 213
5.4 Analyses for higher order two treatment designs 225
5.5 The general linear mixed model 234
5.6 Analysis of repeated measurements within periods 235
5.7 Cross over data as repeated measurements 246
5.8 Case study: an analysis of a trial with many periods 263
6 Analysis of categorical data 281
6.1 Introduction 281
6.2 Binary data: subject effect models 286
6.3 Binary data: marginal models 303
6.4 Categorical data 308
6.5 Further topics 318
7 Bioequivalence trials 323
7.1 What is bioequivalence? 323
7.2 Testing for average bioequivalence 327
7.3 Power and sample size for ABE in the 2x2 design 336
CONTENTS xi
7.4 Individual bioequivalence 337
7.5 Population bioequivalence 343
7.6 ABE for a replicate design 345
7.7 Kullback Leibler divergence 346
7.8 Modelling pharmacokinetic data 347
A Least squares estimation 351
B SAS code for assessing ABE, IBE and PBE 355
References 359
Index 377 |
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| spelling | Jones, Byron Verfasser aut Design and analysis of cross-over trials Byron Jones and Michael G. Kenward 2. ed. Boca Raton, FL [u.a.] Chapman & Hall/CRC 2003 XXV, 382 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Monographs on statistics and applied probability 98 Literaturverz. S. 359 - 376 Experimenteel ontwerp gtt Variantieanalyse gtt Études croisées Statistik Clinical Trials as Topic methods Statistics Cross-Over Studies Statistics Crossover trials Research Design Statistics Experiment (DE-588)4015999-1 gnd rswk-swf Statistik (DE-588)4056995-0 gnd rswk-swf Biostatistik (DE-588)4729990-3 gnd rswk-swf Versuchsplanung (DE-588)4078859-3 gnd rswk-swf Statistics Statistik (DE-588)4056995-0 s DE-604 Versuchsplanung (DE-588)4078859-3 s Biostatistik (DE-588)4729990-3 s Experiment (DE-588)4015999-1 s 1\p DE-604 Kenward, Michael G. Verfasser aut Monographs on statistics and applied probability 98 (DE-604)BV002494005 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015360428&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Jones, Byron Kenward, Michael G. Design and analysis of cross-over trials Monographs on statistics and applied probability Experimenteel ontwerp gtt Variantieanalyse gtt Études croisées Statistik Clinical Trials as Topic methods Statistics Cross-Over Studies Statistics Crossover trials Research Design Statistics Experiment (DE-588)4015999-1 gnd Statistik (DE-588)4056995-0 gnd Biostatistik (DE-588)4729990-3 gnd Versuchsplanung (DE-588)4078859-3 gnd |
| subject_GND | (DE-588)4015999-1 (DE-588)4056995-0 (DE-588)4729990-3 (DE-588)4078859-3 |
| title | Design and analysis of cross-over trials |
| title_auth | Design and analysis of cross-over trials |
| title_exact_search | Design and analysis of cross-over trials |
| title_exact_search_txtP | Design and analysis of cross-over trials |
| title_full | Design and analysis of cross-over trials Byron Jones and Michael G. Kenward |
| title_fullStr | Design and analysis of cross-over trials Byron Jones and Michael G. Kenward |
| title_full_unstemmed | Design and analysis of cross-over trials Byron Jones and Michael G. Kenward |
| title_short | Design and analysis of cross-over trials |
| title_sort | design and analysis of cross over trials |
| topic | Experimenteel ontwerp gtt Variantieanalyse gtt Études croisées Statistik Clinical Trials as Topic methods Statistics Cross-Over Studies Statistics Crossover trials Research Design Statistics Experiment (DE-588)4015999-1 gnd Statistik (DE-588)4056995-0 gnd Biostatistik (DE-588)4729990-3 gnd Versuchsplanung (DE-588)4078859-3 gnd |
| topic_facet | Experimenteel ontwerp Variantieanalyse Études croisées Statistik Clinical Trials as Topic methods Statistics Cross-Over Studies Statistics Crossover trials Research Design Statistics Experiment Biostatistik Versuchsplanung Statistics |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015360428&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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