Dose optimization in drug development:
Saved in:
| Format: | Book |
|---|---|
| Language: | English |
| Published: |
New York [u.a.]
Taylor & Francis
2006
|
| Series: | Drugs and the pharmaceutical sciences
161 |
| Subjects: | |
| Online Access: | Publisher description Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XIV, 293 S. Ill., graph. Darst. |
| ISBN: | 1574448080 9781574448085 |
Staff View
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| 245 | 1 | 0 | |a Dose optimization in drug development |c ed. by Rajesh Krishna |
| 264 | 1 | |a New York [u.a.] |b Taylor & Francis |c 2006 | |
| 300 | |a XIV, 293 S. |b Ill., graph. Darst. | ||
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Record in the Search Index
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| adam_text | Contents
Foreword Barry J. Gertz . . . . v
Preface .... vii
Contributors .... xiii
1. Introduction to Dose Optimization in Drug Development 1
Rajesh Krishna
Introduction . . . . 1
Changing Face of Regulatory Environment .... 2
New Technologies for Drug Development . . . . 4
Risk Versus Benefit Assessment . . . . 8
Implications on Dose Optimization .... 10
References .... 10
2. Bridging Preclinical and Clinical Development: Disease
Progression Modeling in Translational Research 15
Paolo Vicini
Introduction .... 75
Biomarkers and Disease Progression Modeling .... 17
A Role for Informatics and Computational Biology .... 18
Finding and Validating Model Based Biomarkers .... 20
Conclusion .... 28
References .... 29
3. Bridging Preclinical and Clinical Development: Biomarker
Validation and Qualification 35
John A. Wagner
Introduction .... 55
Definitions .... 37
Validation and Qualification .... 39
lx
x Contents
Application of Validation and Qualification to
Selected Biomarkers .... 42
Summary .... 43
References .... 43
4. Dose Selection for First in Human (FIH) Trials—Regulatory
Perspective 45
Lois M. Freed
Introduction .... 45
Approach for Selecting the MRSD for
FIH Trials of NMEs in Adult Healthy Volunteers .... 46
Basis for CDER s Approach for Selecting a Maximum
Safe Starting Dose for FIH Trials in Healthy Volunteers 47
Validation .... 52
Alternative Approaches to Estimation of MRSD
for FIH Trial in Healthy Volunteers .... 55
Survey of Industry Approaches .... 55
Conclusions .... 56
References .... 57
5. Novel Clinical Trial Designs in Clinical Pharmacology and
Experimental Medicine 61
Rajesh Krishna and James Bolognese
Introduction .... 61
Conventional Designs .... 62
Impetus for Novel Designs .... 66
Modeling and Simulations for Clinical Trial Designs .... 75
Summary .... 79
References .... 79
6. Biomarkers, Surrogate Endpoints, and Clinical Endpoints
in the Development of Cardiovascular Drugs:
A Regulatory Perspective #5
Peter H. Hinderling and Patrick J. Marroum
The Current Paradigm of Drug Development .... 85
Drug Response Measures .... 86
Acceptable Surrogate Endpoints and Biomarkers
for Demonstrating Efficacy or Assessing the
Toxic Potential of Drugs .... 87
Acceptable Biomarkers When Efficacy and Safety
Are Established by Other Data .... 88
Relevance of and Current Issues with Biomarkers .... 90
Appendix .... 93
References .... 94
Contents xi
7. PK and PD Variability—Estimation and Appraisal of
Its Impact on Dose Optimization with an Example of
Gender Differences 97
Vladimir Piotrovsky
Introduction .... 97
Mechanistic Consideration .... 700
Population Modeling: Statistical Framework .... 104
PK Differences Between Males and Females .... 110
Gender Differences in PD and Clinical Endpoints .... 722
Pitfalls in Estimating and Interpreting Effects of
Subject Demographics .... 130
Population Modeling and Simulation as a Tool for Dose
Optimization in Drug Development .... 132
Conclusion .... 142
References .... 143
8. Pharmacogenetics (PGx) and Dose Response: Dose
Individualization 159
Wolfgang M. Schmidt and Markus Miiller
Summary .... 759
Introduction .... 760
PGx, Drug Dose, and Safety .... 163
PK and Drug Metabolism .... 770
PD and Drug Efficacy 774
Pharmacogenomics, Expression Signatures, and
Predictive Biomarkers .... 775
Current Challenges .... 181
Outlook .... 184
Conclusion .... 785
References .... 785
9. Optimal Dose Finding in Drug Development: Approaches
and Regulatory Perspectives 195
Jogarao V. S. Gobburu and Mathangi Gopalakrishnan
Introduction .... 795
Nomenclature .... 796
Current Legal Requirements and Regulatory Expectations .... 796
The Need for Better Dose Finding Studies .... 797
Approaches for Finding Optimal Dose .... 200
Future Considerations .... 270
References .... 272
xii Contents
10. Optimal Dose Selection in Drug Development: Role of Population
Pharmacokinetics in Phase III 277
Willi Weber and Diether Rueppel
Introduction .... 217
The Learning and Confirming Concept .... 219
Development of a Cardioprotective Drug .... 222
Conclusion .... 243
Appendix .... 244
References .... 245
11. Dose Optimization Strategy for Strattera®,
a CYP2D6 Substrate 247
Jennifer W. Witcher, Stephan Chalon, and
John Michael Sauer
Introduction .... 247
Background .... 248
PK and Metabolism, Influence of Pharmacogenetics .... 248
Development Strategy for a CYP2D6 Substrate .... 251
Efficacy and Safety Studies .... 253
Dose Response and PK/PD Modeling .... 254
Dosing Recommendations and Labeling .... 255
References .... 258
12. Pediatric Dose Optimization Using Pharmacokinetics
and Pharmacodynamics 261
Jun Shi
Introduction .... 267
General Considerations of PK/PD Study Design and
Date Analysis in Pediatrics .... 262
Population PK PD of Sotalol in Pediatric Patients with
Supraventricular or Ventricular Tachyarrhythmia .... 266
Population PK of the Active Metabolite of
Leflunomide in Pediatric Subjects with Polyarticular
Course Juvenile Rheumatoid Arthritis .... 274
Conclusion .... 283
References .... 284
Index 287
|
| adam_txt |
Contents
Foreword Barry J. Gertz . . . . v
Preface . vii
Contributors . xiii
1. Introduction to Dose Optimization in Drug Development 1
Rajesh Krishna
Introduction . . . . 1
Changing Face of Regulatory Environment . 2
New Technologies for Drug Development . . . . 4
Risk Versus Benefit Assessment . . . . 8
Implications on Dose Optimization . 10
References . 10
2. Bridging Preclinical and Clinical Development: Disease
Progression Modeling in Translational Research 15
Paolo Vicini
Introduction . 75
Biomarkers and Disease Progression Modeling . 17
A Role for Informatics and Computational Biology . 18
Finding and Validating Model Based Biomarkers . 20
Conclusion . 28
References . 29
3. Bridging Preclinical and Clinical Development: Biomarker
Validation and Qualification 35
John A. Wagner
Introduction . 55
Definitions . 37
Validation and Qualification . 39
lx
x Contents
Application of Validation and Qualification to
Selected Biomarkers . 42
Summary . 43
References . 43
4. Dose Selection for First in Human (FIH) Trials—Regulatory
Perspective 45
Lois M. Freed
Introduction . 45
Approach for Selecting the MRSD for
FIH Trials of NMEs in Adult Healthy Volunteers . 46
Basis for CDER's Approach for Selecting a Maximum
Safe Starting Dose for FIH Trials in Healthy Volunteers 47
Validation . 52
Alternative Approaches to Estimation of MRSD
for FIH Trial in Healthy Volunteers . 55
Survey of Industry Approaches . 55
Conclusions . 56
References . 57
5. Novel Clinical Trial Designs in Clinical Pharmacology and
Experimental Medicine 61
Rajesh Krishna and James Bolognese
Introduction . 61
Conventional Designs . 62
Impetus for Novel Designs . 66
Modeling and Simulations for Clinical Trial Designs . 75
Summary . 79
References . 79
6. Biomarkers, Surrogate Endpoints, and Clinical Endpoints
in the Development of Cardiovascular Drugs:
A Regulatory Perspective #5
Peter H. Hinderling and Patrick J. Marroum
The Current Paradigm of Drug Development . 85
Drug Response Measures . 86
Acceptable Surrogate Endpoints and Biomarkers
for Demonstrating Efficacy or Assessing the
Toxic Potential of Drugs . 87
Acceptable Biomarkers When Efficacy and Safety
Are Established by Other Data . 88
Relevance of and Current Issues with Biomarkers . 90
Appendix . 93
References . 94
Contents xi
7. PK and PD Variability—Estimation and Appraisal of
Its Impact on Dose Optimization with an Example of
Gender Differences 97
Vladimir Piotrovsky
Introduction . 97
Mechanistic Consideration . 700
Population Modeling: Statistical Framework . 104
PK Differences Between Males and Females . 110
Gender Differences in PD and Clinical Endpoints . 722
Pitfalls in Estimating and Interpreting Effects of
Subject Demographics . 130
Population Modeling and Simulation as a Tool for Dose
Optimization in Drug Development . 132
Conclusion . 142
References . 143
8. Pharmacogenetics (PGx) and Dose Response: Dose
Individualization 159
Wolfgang M. Schmidt and Markus Miiller
Summary . 759
Introduction . 760
PGx, Drug Dose, and Safety . 163
PK and Drug Metabolism . 770
PD and Drug Efficacy 774
Pharmacogenomics, Expression Signatures, and
Predictive Biomarkers . 775
Current Challenges . 181
Outlook . 184
Conclusion . 785
References . 785
9. Optimal Dose Finding in Drug Development: Approaches
and Regulatory Perspectives 195
Jogarao V. S. Gobburu and Mathangi Gopalakrishnan
Introduction . 795
Nomenclature . 796
Current Legal Requirements and Regulatory Expectations . 796
The Need for Better Dose Finding Studies . 797
Approaches for Finding Optimal Dose . 200
Future Considerations . 270
References . 272
xii Contents
10. Optimal Dose Selection in Drug Development: Role of Population
Pharmacokinetics in Phase III 277
Willi Weber and Diether Rueppel
Introduction . 217
The Learning and Confirming Concept . 219
Development of a Cardioprotective Drug . 222
Conclusion . 243
Appendix . 244
References . 245
11. Dose Optimization Strategy for Strattera®,
a CYP2D6 Substrate 247
Jennifer W. Witcher, Stephan Chalon, and
John Michael Sauer
Introduction . 247
Background . 248
PK and Metabolism, Influence of Pharmacogenetics . 248
Development Strategy for a CYP2D6 Substrate . 251
Efficacy and Safety Studies . 253
Dose Response and PK/PD Modeling . 254
Dosing Recommendations and Labeling . 255
References . 258
12. Pediatric Dose Optimization Using Pharmacokinetics
and Pharmacodynamics 261
Jun Shi
Introduction . 267
General Considerations of PK/PD Study Design and
Date Analysis in Pediatrics . 262
Population PK PD of Sotalol in Pediatric Patients with
Supraventricular or Ventricular Tachyarrhythmia . 266
Population PK of the Active Metabolite of
Leflunomide in Pediatric Subjects with Polyarticular
Course Juvenile Rheumatoid Arthritis . 274
Conclusion . 283
References . 284
Index 287 |
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| spelling | Dose optimization in drug development ed. by Rajesh Krishna New York [u.a.] Taylor & Francis 2006 XIV, 293 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 161 Includes bibliographical references and index Drugs Dose-response relationship Drugs Dosage Drug development Pharmaceutical Preparations administration & dosage Pharmacokinetics Dose-Response Relationship, Drug Arzneimittelentwicklung (DE-588)4143176-5 gnd rswk-swf Dosis-Wirkungs-Beziehung (DE-588)4130752-5 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Arzneimittelentwicklung (DE-588)4143176-5 s Dosis-Wirkungs-Beziehung (DE-588)4130752-5 s b DE-604 Krishna, Rajesh Sonstige oth Drugs and the pharmaceutical sciences 161 (DE-604)BV000002008 161 http://www.loc.gov/catdir/enhancements/fy0648/2005046645-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=014917846&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Dose optimization in drug development Drugs and the pharmaceutical sciences Drugs Dose-response relationship Drugs Dosage Drug development Pharmaceutical Preparations administration & dosage Pharmacokinetics Dose-Response Relationship, Drug Arzneimittelentwicklung (DE-588)4143176-5 gnd Dosis-Wirkungs-Beziehung (DE-588)4130752-5 gnd |
| subject_GND | (DE-588)4143176-5 (DE-588)4130752-5 (DE-588)4143413-4 |
| title | Dose optimization in drug development |
| title_auth | Dose optimization in drug development |
| title_exact_search | Dose optimization in drug development |
| title_exact_search_txtP | Dose optimization in drug development |
| title_full | Dose optimization in drug development ed. by Rajesh Krishna |
| title_fullStr | Dose optimization in drug development ed. by Rajesh Krishna |
| title_full_unstemmed | Dose optimization in drug development ed. by Rajesh Krishna |
| title_short | Dose optimization in drug development |
| title_sort | dose optimization in drug development |
| topic | Drugs Dose-response relationship Drugs Dosage Drug development Pharmaceutical Preparations administration & dosage Pharmacokinetics Dose-Response Relationship, Drug Arzneimittelentwicklung (DE-588)4143176-5 gnd Dosis-Wirkungs-Beziehung (DE-588)4130752-5 gnd |
| topic_facet | Drugs Dose-response relationship Drugs Dosage Drug development Pharmaceutical Preparations administration & dosage Pharmacokinetics Dose-Response Relationship, Drug Arzneimittelentwicklung Dosis-Wirkungs-Beziehung Aufsatzsammlung |
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