Bioequivalence studies in drug development: methods and applications
Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance...
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| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Chichester, West Sussex, England
Wiley
2007
|
| Series: | Statistics in practice
|
| Subjects: | |
| Online Access: | Table of contents only Contributor biographical information Publisher description Inhaltsverzeichnis |
| Summary: | Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. |
| Item Description: | Includes bibliographical references and indexes |
| Physical Description: | XI, 311 S. graph. Darst. 25 cm |
| ISBN: | 0470094753 9780470094754 |
Staff View
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| 245 | 1 | 0 | |a Bioequivalence studies in drug development |b methods and applications |c Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| 264 | 1 | |a Chichester, West Sussex, England |b Wiley |c 2007 | |
| 300 | |a XI, 311 S. |b graph. Darst. |c 25 cm | ||
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| 490 | 0 | |a Statistics in practice | |
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| 520 | 3 | |a Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. | |
| 650 | 4 | |a Médicaments - Équivalence thérapeutique | |
| 650 | 4 | |a Drugs |x Therapeutic equivalency | |
| 650 | 4 | |a Therapeutic Equivalency | |
| 650 | 4 | |a Clinical Trials |x methods | |
| 650 | 4 | |a Drug Design | |
| 700 | 1 | |a Steinijans, Volker W. |e Sonstige |4 oth | |
| 700 | 1 | |a Pigeot, Iris |d 1960- |e Sonstige |0 (DE-588)172308437 |4 oth | |
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Record in the Search Index
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| adam_text | Contents
Preface xiii
1 Introduction 1
1.1 Definitions 1
1.1.1 Bioavailability 2
1.1.2 Bioequivalence 2
1.1.3 Therapeutic equivalence 3
1.2 When are bioequivalence studies performed 4
1.2.1 Applications for products containing new active substances 4
1.2.2 Applications for products containing approved active
substances 4
1.2.3 Applications for modified release forms essentially similar to a
marketed modified release form 4
1.3 Design and conduct of bioequivalence studies 5
1.3.1 Crossover design and alternatives 5
1.3.2 Single- vs. multiple-dose studies 6
1.3.3 Pharmacokinetic characteristics 6
1.3.4 Subjects 7
1.3.5 Statistical models 8
1.3.5.1 Average bioequivalence 8
1.3.5.2 Population bioequivalence 9
1.3.5.3 Individual bioequivalence 11
1.3.6 Sample size 12
1.4 Aims and structure of the book 14
References 15
2 Metrics to characterize concentration-time profiles in single- and
multiple-dose bioequivalence studies 17
2.1 Introduction 17
2.2 Pharmacokinetic characteristics (metrics) for single-dose studies 20
2.2.1 Extent of bioavailability 20
2.2.2 Rate of bioavailability 24
viii CONTENTS
2.3 Pharmacokinetic rate and extent characteristics (metrics) for
multiple-dose studies 26
2.4 Conclusions 34
References 34
3 Basic statistical considerations 37
3.1 Introduction 37
3.2 Additive and multiplicative model 38
3.2.1 The normal distribution 38
3.2.2 The lognormal distribution 41
3.3 Hypotheses testing 44
3.3.1 Consumer and producer risk 44
3.3.2 Types of hypotheses 46
3.3.2.1 Test for difference 47
3.3.2.2 Test for superiority 47
3.3.2.3 Test for noninferiority 48
3.3.2.4 Test for equivalence 49
3.3.3 Difference versus ratio of expected means 51
3.3.3.1 The normal distribution 51
3.3.3.2 The lognormal distribution 53
3.4 The RT/TR crossover design assuming an additive model 55
3.4.1 Additive model and effects 55
3.4.2 Parametric analysis based on Mests 56
3.4.2.1 Test for difference in carryover effects 59
3.4.2.2 Test for difference in formulation effects 60
3.4.2.3 Test for difference in period effects 63
3.4.3 Nonparametric analysis based on Wilcoxon rank sum tests 65
3.4.3.1 Test for difference in carryover effects 65
3.4.3.2 Test for difference in formulation effects 66
3.4.3.3 Test for difference in period effects 67
References 68
4 Assessment of average bioequivalence in the RT/TR design 69
4.1 Introduction 69
4.2 The RT/TR crossover design assuming a multiplicative model 72
4.2.1 Multiplicative model and effects 73
4.2.2 Test problem 75
4.2.3 Estimation of the formulation difference 77
4.3 Test procedures for bioequivalence assessment 80
4.3.1 Analysis of variance 80
4.3.1.1 Example: Dose equivalence study 84
4.3.2 Two one-sided Mests and (1 - 2a) 100 % confidence interval 89
4.3.2.1 Example: Dose equivalence study 91
4.3.3 Two one-sided Wilcoxon rank sum tests and (1 — 2a) 100 %
confidence interval 94
CONTENTS ix
4.3.3.1 Example: Dose equivalence study 96
4.3.3.2 Analysis of time to maximum concentration 97
4.3.4 Bioequivalence ranges 101
4.4 Conclusions 103
References 103
5 Power and sample size determination for testing average
bioequivalence in the RT/TR design 105
5.1 Introduction 105
5.2 Challenging the classical approach 106
5.3 Exact power and sample size calculation 109
5.4 Modified acceptance ranges 112
5.5 Approximate formulas for sample size calculation 114
5.6 Exact power and sample size calculation by nQuery® 117
Appendix 120
References 121
6 Presentation of bioequivalence studies 123
6.1 Introduction 123
6.2 Results from a single-dose study 124
6.3 Results from a multiple-dose study 140
6.4 Conclusions 152
References 154
7 Designs with more than two formulations 157
7.1 Introduction 157
7.2 Williams designs 158
7.3 Example: Dose linearity study 159
7.4 Multiplicity 161
7.4.1 Joint decision rule 165
7.4.2 Multiple decision rule 171
7.5 Conclusions 172
References 172
8 Analysis of pharmacokinetic interactions 175
8.1 Introduction 175
8.2 Pharmacokinetic drug-drug interaction studies 178
8.2.1 Absorption 178
8.2.2 Distribution 178
8.2.3 Elimination 178
8.2.3.1 Metabolism 179
8.2.3.1.1 Metabolic induction 179
8.2.3.1.2 Metabolic inhibition 181
8.2.3.1.3 Change of blood flow 182
x CONTENTS
8.2.3.2 Renal excretion 182
8.2.3.3 Hepatic/biliary excretion 183
8.2.4 Experimental design of in vivo drug-drug interaction studies... 183
8.2.5 Examples to illustrate drug-drug interactions and the lack
thereof 184
8.2.6 Pharmacokinetic characteristics for extent of absorption and
clearance in drug-drug interaction studies 187
8.2.6.1 Theoretical background on AUC as a composite
measure of absorption and clearance 190
8.2.6.2 Examples to illustrate the composite character of
AUC 192
8.2.6.3 Recommendation for subsequent analyses 193
8.3 Pharmacokinetic food-drug interactions 194
8.3.1 Classification of food effects 194
8.3.2 Experimental design of food-drug interaction studies 196
8.3.3 Example: Theophylline food interaction study 197
8.4 Goal posts for pharmacokinetic drug interaction studies including no
effect boundaries 197
8.5 Labeling 199
8.6 Conclusions 200
References 200
9 Population and individual bioequivalence 205
9.1 Introduction 205
9.2 Brief history 208
9.3 Study designs and statistical models 210
9.3.1 Classical two-period, two-sequence crossover design 210
9.3.2 Replicate designs 210
9.3.3 Additive model 212
9.3.4 Basic concepts of aggregate measures 213
9.3.5 Example: The antihypertensive patch dataset 215
9.4 Population bioequivalence 217
9.4.1 Moment-based criteria 217
9.4.1.1 Statistical procedures 219
9.4.1.1.1 The bootstrap procedure 219
9.4.1.1.2 A parametric confidence interval 220
9.4.2 Probability-based criteria 225
9.4.2.1 Statistical procedures 225
9.4.2.1.1 A distribution-free approach 225
9.4.2.1.2 A parametric approach 228
9.5 Individual bioequivalence 230
9.5.1 Moment-based criteria 230
9.5.1.1 Statistical procedures 232
9.5.1.1.1 The bootstrap procedure 232
9.5.1.1.2 A parametric confidence interval 233
CONTENTS xi
9.5.2 Probability-based criteria 236
9.5.2.1 Statistical procedures 236
9.5.2.1.1 A distribution-free approach 237
9.5.2.1.2 A parametric approach 239
9.5.2.1.3 Test for individual equivalence
ratio (TIER) 241
9.5.3 Relationships between aggregate bioequivalence criteria 243
9.5.4 Drawbacks of aggregate measures 245
9.6 Disaggregate criteria 246
9.6.1 Stepwise procedure on the original scale 246
9.6.2 Stepwise procedure on the logarithmic scale 253
9.7 Other approaches 255
9.7.1 Trimmed Mallows distance 255
9.7.2 Kullback-Leibler divergence 256
9.7.3 Structural equation model 257
9.8 Average bioequivalence in replicate designs 258
9.9 Example: The antihypertensive patch dataset 259
9.10 Conclusions 278
References 280
10 Equivalence assessment for clinical endpoints 283
10.1 Introduction 283
10.2 Design and testing procedure 285
10.2.1 Parallel group design 285
10.2.2 Crossover design 287
10.3 Power and sample size calculation 289
10.3.1 Parallel group design 289
10.3.2 Crossover design 292
10.3.3 Approximate formulas for sample size calculation 297
10.3.4 Exact power and sample size calculation by nQuery® 302
10.4 Conclusions 303
Appendix 304
References 305
Index 307
|
| adam_txt |
Contents
Preface xiii
1 Introduction 1
1.1 Definitions 1
1.1.1 Bioavailability 2
1.1.2 Bioequivalence 2
1.1.3 Therapeutic equivalence 3
1.2 When are bioequivalence studies performed 4
1.2.1 Applications for products containing new active substances 4
1.2.2 Applications for products containing approved active
substances 4
1.2.3 Applications for modified release forms essentially similar to a
marketed modified release form 4
1.3 Design and conduct of bioequivalence studies 5
1.3.1 Crossover design and alternatives 5
1.3.2 Single- vs. multiple-dose studies 6
1.3.3 Pharmacokinetic characteristics 6
1.3.4 Subjects 7
1.3.5 Statistical models 8
1.3.5.1 Average bioequivalence 8
1.3.5.2 Population bioequivalence 9
1.3.5.3 Individual bioequivalence 11
1.3.6 Sample size 12
1.4 Aims and structure of the book 14
References 15
2 Metrics to characterize concentration-time profiles in single- and
multiple-dose bioequivalence studies 17
2.1 Introduction 17
2.2 Pharmacokinetic characteristics (metrics) for single-dose studies 20
2.2.1 Extent of bioavailability 20
2.2.2 Rate of bioavailability 24
viii CONTENTS
2.3 Pharmacokinetic rate and extent characteristics (metrics) for
multiple-dose studies 26
2.4 Conclusions 34
References 34
3 Basic statistical considerations 37
3.1 Introduction 37
3.2 Additive and multiplicative model 38
3.2.1 The normal distribution 38
3.2.2 The lognormal distribution 41
3.3 Hypotheses testing 44
3.3.1 Consumer and producer risk 44
3.3.2 Types of hypotheses 46
3.3.2.1 Test for difference 47
3.3.2.2 Test for superiority 47
3.3.2.3 Test for noninferiority 48
3.3.2.4 Test for equivalence 49
3.3.3 Difference versus ratio of expected means 51
3.3.3.1 The normal distribution 51
3.3.3.2 The lognormal distribution 53
3.4 The RT/TR crossover design assuming an additive model 55
3.4.1 Additive model and effects 55
3.4.2 Parametric analysis based on Mests 56
3.4.2.1 Test for difference in carryover effects 59
3.4.2.2 Test for difference in formulation effects 60
3.4.2.3 Test for difference in period effects 63
3.4.3 Nonparametric analysis based on Wilcoxon rank sum tests 65
3.4.3.1 Test for difference in carryover effects 65
3.4.3.2 Test for difference in formulation effects 66
3.4.3.3 Test for difference in period effects 67
References 68
4 Assessment of average bioequivalence in the RT/TR design 69
4.1 Introduction 69
4.2 The RT/TR crossover design assuming a multiplicative model 72
4.2.1 Multiplicative model and effects 73
4.2.2 Test problem 75
4.2.3 Estimation of the formulation difference 77
4.3 Test procedures for bioequivalence assessment 80
4.3.1 Analysis of variance 80
4.3.1.1 Example: Dose equivalence study 84
4.3.2 Two one-sided Mests and (1 - 2a) 100 % confidence interval 89
4.3.2.1 Example: Dose equivalence study 91
4.3.3 Two one-sided Wilcoxon rank sum tests and (1 — 2a) 100 %
confidence interval 94
CONTENTS ix
4.3.3.1 Example: Dose equivalence study 96
4.3.3.2 Analysis of time to maximum concentration 97
4.3.4 Bioequivalence ranges 101
4.4 Conclusions 103
References 103
5 Power and sample size determination for testing average
bioequivalence in the RT/TR design 105
5.1 Introduction 105
5.2 Challenging the classical approach 106
5.3 Exact power and sample size calculation 109
5.4 Modified acceptance ranges 112
5.5 Approximate formulas for sample size calculation 114
5.6 Exact power and sample size calculation by nQuery® 117
Appendix 120
References 121
6 Presentation of bioequivalence studies 123
6.1 Introduction 123
6.2 Results from a single-dose study 124
6.3 Results from a multiple-dose study 140
6.4 Conclusions 152
References 154
7 Designs with more than two formulations 157
7.1 Introduction 157
7.2 Williams designs 158
7.3 Example: Dose linearity study 159
7.4 Multiplicity 161
7.4.1 Joint decision rule 165
7.4.2 Multiple decision rule 171
7.5 Conclusions 172
References 172
8 Analysis of pharmacokinetic interactions 175
8.1 Introduction 175
8.2 Pharmacokinetic drug-drug interaction studies 178
8.2.1 Absorption 178
8.2.2 Distribution 178
8.2.3 Elimination 178
8.2.3.1 Metabolism 179
8.2.3.1.1 Metabolic induction 179
8.2.3.1.2 Metabolic inhibition 181
8.2.3.1.3 Change of blood flow 182
x CONTENTS
8.2.3.2 Renal excretion 182
8.2.3.3 Hepatic/biliary excretion 183
8.2.4 Experimental design of in vivo drug-drug interaction studies. 183
8.2.5 Examples to illustrate drug-drug interactions and the lack
thereof 184
8.2.6 Pharmacokinetic characteristics for extent of absorption and
clearance in drug-drug interaction studies 187
8.2.6.1 Theoretical background on AUC as a composite
measure of absorption and clearance 190
8.2.6.2 Examples to illustrate the composite character of
AUC 192
8.2.6.3 Recommendation for subsequent analyses 193
8.3 Pharmacokinetic food-drug interactions 194
8.3.1 Classification of food effects 194
8.3.2 Experimental design of food-drug interaction studies 196
8.3.3 Example: Theophylline food interaction study 197
8.4 Goal posts for pharmacokinetic drug interaction studies including no
effect boundaries 197
8.5 Labeling 199
8.6 Conclusions 200
References 200
9 Population and individual bioequivalence 205
9.1 Introduction 205
9.2 Brief history 208
9.3 Study designs and statistical models 210
9.3.1 Classical two-period, two-sequence crossover design 210
9.3.2 Replicate designs 210
9.3.3 Additive model 212
9.3.4 Basic concepts of aggregate measures 213
9.3.5 Example: The antihypertensive patch dataset 215
9.4 Population bioequivalence 217
9.4.1 Moment-based criteria 217
9.4.1.1 Statistical procedures 219
9.4.1.1.1 The bootstrap procedure 219
9.4.1.1.2 A parametric confidence interval 220
9.4.2 Probability-based criteria 225
9.4.2.1 Statistical procedures 225
9.4.2.1.1 A distribution-free approach 225
9.4.2.1.2 A parametric approach 228
9.5 Individual bioequivalence 230
9.5.1 Moment-based criteria 230
9.5.1.1 Statistical procedures 232
9.5.1.1.1 The bootstrap procedure 232
9.5.1.1.2 A parametric confidence interval 233
CONTENTS xi
9.5.2 Probability-based criteria 236
9.5.2.1 Statistical procedures 236
9.5.2.1.1 A distribution-free approach 237
9.5.2.1.2 A parametric approach 239
9.5.2.1.3 Test for individual equivalence
ratio (TIER) 241
9.5.3 Relationships between aggregate bioequivalence criteria 243
9.5.4 Drawbacks of aggregate measures 245
9.6 Disaggregate criteria 246
9.6.1 Stepwise procedure on the original scale 246
9.6.2 Stepwise procedure on the logarithmic scale 253
9.7 Other approaches 255
9.7.1 Trimmed Mallows distance 255
9.7.2 Kullback-Leibler divergence 256
9.7.3 Structural equation model 257
9.8 Average bioequivalence in replicate designs 258
9.9 Example: The antihypertensive patch dataset 259
9.10 Conclusions 278
References 280
10 Equivalence assessment for clinical endpoints 283
10.1 Introduction 283
10.2 Design and testing procedure 285
10.2.1 Parallel group design 285
10.2.2 Crossover design 287
10.3 Power and sample size calculation 289
10.3.1 Parallel group design 289
10.3.2 Crossover design 292
10.3.3 Approximate formulas for sample size calculation 297
10.3.4 Exact power and sample size calculation by nQuery® 302
10.4 Conclusions 303
Appendix 304
References 305
Index 307 |
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Darst.</subfield><subfield code="c">25 cm</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="b">n</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="b">nc</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="490" ind1="0" ind2=" "><subfield code="a">Statistics in practice</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Includes bibliographical references and indexes</subfield></datafield><datafield tag="520" ind1="3" ind2=" "><subfield code="a">Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. 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| id | DE-604.BV023290836 |
| illustrated | Illustrated |
| index_date | 2024-07-02T20:43:08Z |
| indexdate | 2024-07-09T21:15:05Z |
| institution | BVB |
| isbn | 0470094753 9780470094754 |
| language | English |
| lccn | 2006029953 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016475451 |
| oclc_num | 71328353 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM DE-578 |
| owner_facet | DE-19 DE-BY-UBM DE-578 |
| physical | XI, 311 S. graph. Darst. 25 cm |
| publishDate | 2007 |
| publishDateSearch | 2007 |
| publishDateSort | 2007 |
| publisher | Wiley |
| record_format | marc |
| series2 | Statistics in practice |
| spelling | Hauschke, Dieter Verfasser aut Bioequivalence studies in drug development methods and applications Dieter Hauschke, Volker Steinijans, Iris Pigeot Chichester, West Sussex, England Wiley 2007 XI, 311 S. graph. Darst. 25 cm txt rdacontent n rdamedia nc rdacarrier Statistics in practice Includes bibliographical references and indexes Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects required by regulatory authorities. This text presents the required statistical methods, and with an outstanding practical emphasis, demonstrates their applications through numerous examples using real data from drug development. Includes all the necessary pharmacokinetic background information. Presents parametric and nonparametric statistical techniques. Describes adequate methods for power and sample size determination. Includes appropriate presentation of results from bioequivalence studies. Provides a practical overview of the design and analysis of bioequivalence studies. Presents the recent developments in methodology, including population and individual bioequivalence. Reviews the regulatory guidelines for such studies, and the existing global discrepancies. Discusses the designs and analyses of drug-drug and food-drug interaction studies. Médicaments - Équivalence thérapeutique Drugs Therapeutic equivalency Therapeutic Equivalency Clinical Trials methods Drug Design Steinijans, Volker W. Sonstige oth Pigeot, Iris 1960- Sonstige (DE-588)172308437 oth http://www.loc.gov/catdir/toc/ecip0620/2006029953.html Table of contents only http://www.loc.gov/catdir/enhancements/fy0740/2006029953-b.html Contributor biographical information http://www.loc.gov/catdir/enhancements/fy0740/2006029953-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=016475451&sequence=000006&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Hauschke, Dieter Bioequivalence studies in drug development methods and applications Médicaments - Équivalence thérapeutique Drugs Therapeutic equivalency Therapeutic Equivalency Clinical Trials methods Drug Design |
| title | Bioequivalence studies in drug development methods and applications |
| title_auth | Bioequivalence studies in drug development methods and applications |
| title_exact_search | Bioequivalence studies in drug development methods and applications |
| title_exact_search_txtP | Bioequivalence studies in drug development methods and applications |
| title_full | Bioequivalence studies in drug development methods and applications Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| title_fullStr | Bioequivalence studies in drug development methods and applications Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| title_full_unstemmed | Bioequivalence studies in drug development methods and applications Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| title_short | Bioequivalence studies in drug development |
| title_sort | bioequivalence studies in drug development methods and applications |
| title_sub | methods and applications |
| topic | Médicaments - Équivalence thérapeutique Drugs Therapeutic equivalency Therapeutic Equivalency Clinical Trials methods Drug Design |
| topic_facet | Médicaments - Équivalence thérapeutique Drugs Therapeutic equivalency Therapeutic Equivalency Clinical Trials methods Drug Design |
| url | http://www.loc.gov/catdir/toc/ecip0620/2006029953.html http://www.loc.gov/catdir/enhancements/fy0740/2006029953-b.html http://www.loc.gov/catdir/enhancements/fy0740/2006029953-d.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016475451&sequence=000006&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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