Bioequivalence and statistics in clinical pharmacology:
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Boca Raton
Chapman & Hall
2006
|
| Series: | Chapman & Hall/CRC interdisciplinary statistics series
|
| Subjects: | |
| Online Access: | Publisher description Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references (p. 335-370) and index |
| Physical Description: | xxi, 374 p. ill. 25 cm |
| ISBN: | 1584885300 |
Staff View
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| 650 | 4 | |a Pharmacologie clinique | |
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| 650 | 4 | |a Drugs |x Therapeutic equivalency | |
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Record in the Search Index
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| adam_text | Contents
Preface xi
List of figures xiii
List of tables xv
1 Drug Development and Clinical Pharmacology 1
1.1 Aims of This Book 2
1.2 Drug Development 3
1.3 Clinical Pharmacology 5
1.4 Statistics in Clinical Pharmacology 11
1.5 Structure of the Book 14
2 History and Regulation of Bioequivalence 17
2.1 When and How BE Studies Are Performed 19
2.2 Why Are BE Studies Performed? 27
2.3 Deciding When Formulations Are Bioequivalent 28
2.4 Potential Issues with TOST Bioequivalence 32
2.5 Current International Regulation 36
3 Testing for Average Bioequivalence 39
3.1 Background 39
3.2 Linear Model for 2 x 2 Data 44
3.3 Applying the TOST Procedure 49
3.4 Carry-over, Sequence, and Interaction Effects 52
3.5 Checking Assumptions Made about the Linear Model 56
3.6 Power and Sample Size for ABE in the 2 x 2 Design 58
3.7 Example Where Test and Reference Are Not ABE 61
3.8 Nonparametric Analysis 68
3.9 Some Practical Issues 76
4 BE Studies with More Than Two Periods 79
4.1 Background 80
4.2 Three-period Designs 81
vii
viii CONTENTS
4.3 Within-subject Variability 87
4.4 Robust Analyses for Three Period Designs 90
4.5 Four-period Designs 92
4.6 Designs with More Than Two Treatments 96
4.7 Nonparametric Analyses of Tmax 102
4.8 Technical Appendix: Efficiency 116
4.9 Tables of Data 120
5 Dealing with Unexpected BE Challenges 133
5.1 Restricted Maximum Likelihood Modelling 135
5.2 Failing BE and the DER Assessment 138
5.3 Simulation 143
5.4 Data-based Simulation 145
5.5 Carry-over 147
5.6 Optional Designs 154
5.7 Determining Trial Size 160
5.8 What Outliers Are and How to Handle Their Data 165
5.9 Bayesian BE Assessment 167
5.10 Technical Appendix 170
6 The Future and Recent Past of BE Testing 177
6.1 Brief History 178
6.2 Individual and Population BE 181
6.3 Scaled Average BE 186
7 Clinical Pharmacology Safety Studies 189
7.1 Background 191
7.2 First-time-in-humans 194
7.3 Sub-chronic Dosing Studies 208
7.4 Food-Effect Assessment and DDIs 221
7.5 Dose-Proportionality 233
7.6 Technical Appendix 240
8 QTc 243
8.1 Background 244
8.2 Modelling of QTc Data 247
8.3 Interpreting the QTc Modelling Findings 254
8.4 Design of a Thorough QTc Study in the Future 259
8.5 Technical Appendix 262
9 Clinical Pharmacology Efficacy Studies 269
9.1 Background 270
9.2 Sub-chronic Dosing 274
CONTENTS ix
9.3 Phase Ha and the Proof of Concept 282
9.4 Methodology Studies 294
10 Population Pharmacokinetics 299
10.1 Population and Pharmacokinetics 300
10.2 Absolute and Relative Bioavailability 307
10.3 Age and Gender Pharmacokinetic Studies 311
10.4 Ethnicity 316
10.5 Liver Disease 321
10.6 Kidney Disease 325
10.7 Technical Appendix 328
11 Epilogue 333
Bibliography 335
Index 371
|
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| id | DE-604.BV035946828 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T22:07:54Z |
| institution | BVB |
| isbn | 1584885300 |
| language | English |
| lccn | 2005053753 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-018803959 |
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| physical | xxi, 374 p. ill. 25 cm |
| publishDate | 2006 |
| publishDateSearch | 2006 |
| publishDateSort | 2006 |
| publisher | Chapman & Hall |
| record_format | marc |
| series2 | Chapman & Hall/CRC interdisciplinary statistics series |
| spelling | Patterson, Scott Verfasser aut Bioequivalence and statistics in clinical pharmacology Scott Patterson ; Byron Jones Boca Raton Chapman & Hall 2006 xxi, 374 p. ill. 25 cm txt rdacontent n rdamedia nc rdacarrier Chapman & Hall/CRC interdisciplinary statistics series Includes bibliographical references (p. 335-370) and index Médicaments - Équivalence thérapeutique Pharmacologie clinique Statistiques médicales Statistik Clinical pharmacology Drugs Therapeutic equivalency Medical statistics Pharmacology, Clinical Therapeutic Equivalency Statistics Jones, Byron 1951- Verfasser (DE-588)129573612 aut http://www.loc.gov/catdir/enhancements/fy0648/2005053753-d.html Publisher description HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018803959&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Patterson, Scott Jones, Byron 1951- Bioequivalence and statistics in clinical pharmacology Médicaments - Équivalence thérapeutique Pharmacologie clinique Statistiques médicales Statistik Clinical pharmacology Drugs Therapeutic equivalency Medical statistics Pharmacology, Clinical Therapeutic Equivalency Statistics |
| title | Bioequivalence and statistics in clinical pharmacology |
| title_auth | Bioequivalence and statistics in clinical pharmacology |
| title_exact_search | Bioequivalence and statistics in clinical pharmacology |
| title_full | Bioequivalence and statistics in clinical pharmacology Scott Patterson ; Byron Jones |
| title_fullStr | Bioequivalence and statistics in clinical pharmacology Scott Patterson ; Byron Jones |
| title_full_unstemmed | Bioequivalence and statistics in clinical pharmacology Scott Patterson ; Byron Jones |
| title_short | Bioequivalence and statistics in clinical pharmacology |
| title_sort | bioequivalence and statistics in clinical pharmacology |
| topic | Médicaments - Équivalence thérapeutique Pharmacologie clinique Statistiques médicales Statistik Clinical pharmacology Drugs Therapeutic equivalency Medical statistics Pharmacology, Clinical Therapeutic Equivalency Statistics |
| topic_facet | Médicaments - Équivalence thérapeutique Pharmacologie clinique Statistiques médicales Statistik Clinical pharmacology Drugs Therapeutic equivalency Medical statistics Pharmacology, Clinical Therapeutic Equivalency Statistics |
| url | http://www.loc.gov/catdir/enhancements/fy0648/2005053753-d.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018803959&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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