Herbal supplements - drug interactions: scientific and regulatory perspectives
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
New York [u.a.]
Taylor & Francis
2006
|
| Schriftenreihe: | Drugs and the pharmaceutical sciences
162 |
| Schlagworte: | |
| Online-Zugang: | Publisher description Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XIII, 332 S. Ill., graph. Darst. |
| ISBN: | 0824725387 9780824725389 |
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| 245 | 1 | 0 | |a Herbal supplements - drug interactions |b scientific and regulatory perspectives |c ed. by Y. W. Francis Lam ... |
| 264 | 1 | |a New York [u.a.] |b Taylor & Francis |c 2006 | |
| 300 | |a XIII, 332 S. |b Ill., graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
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| 490 | 1 | |a Drugs and the pharmaceutical sciences |v 162 | |
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Consommateurs - Protection - Droit | |
| 650 | 4 | |a Herbes - Emploi en thérapeutique - Effets secondaires | |
| 650 | 4 | |a Interactions médicaments-herbes | |
| 650 | 4 | |a Recht | |
| 650 | 4 | |a Drug-herb interactions | |
| 650 | 4 | |a Herbs |x Therapeutic use |x Side effects | |
| 650 | 4 | |a Consumer protection |x Law and legislation | |
| 650 | 4 | |a Herb-Drug Interactions | |
| 650 | 4 | |a Consumer Product Safety | |
| 650 | 4 | |a Medicine, Herbal |x legislation & jurisprudence | |
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Datensatz im Suchindex
| _version_ | 1804135500220465152 |
|---|---|
| adam_text | Contents
Preface .... Hi
Contributors .... xi
1. The Landscape of Botanical Medicine Utilization
and Safety /
Andrew Morris and Michael D. Murray
Introduction .... 1
Utilization of Botanical Dietary Supplements
in the United States .... 2
Safety of Botanical Products .... 8
Conclusions .... 19
References .... 19
2. Drug Interactions with Botanical Products 25
Y. W. Francis Lam, Shiew Mei Huang, and Stephen D. Hall
Overview of Botanical Drug Interactions .... 25
Mechanisms of Botanical Drug Interactions .... 26
Altered Pharmacokinetics .... 27
Altered Pharmacodynamics .... 34
Antagonistic Pharmacodynamic Effect .... 37
Evaluating Botanical Drug Interaction .... 38
Confounding Issues Related to Study Design .... 41
Future .... 42
References .... 43
V
vi Contents
3. In Vitro Inhibition with Botanical Products 49
Brian C. Foster, John T. Arnason, and Colin J. Briggs
Background .... 49
Natural Product Variation .... 50
Test Conditions .... 62
Product Selection for Clinical Studies .... 63
Conclusion .... 64
References .... 65
4. Drug Interactions with St. John s Wort
and Echinacea 69
J. Christopher Gorski
Introduction .... 69
St. John s Wort .... 70
Echinacea .... 92
References .... 95
5. Botanical Products Drug Interactions: Focus on Garlic,
Ginkgo and Ginseng 107
Y. W. Francis Lam and E. Ernst
Introduction .... 107
Garlic (Allium Sativum L.) .... 108
Ginkgo (Ginkgo Biloba L.) . . . . 112
Asian Ginseng (Panax Ginseng C. A. Meyer) .... 115
Comment .... 118
References .... 119
6. A Review of Chinese Botanical Product Drug
Interactions 123
Y. W. Francis Lam and Ming Ou
Introduction .... 123
Chinese Botanical Products and Warfarin .... 125
Chinese Botanical Products and Phenprocoumon .... 133
Chinese Botanical Products and Aspirin .... 134
Chinese Botanical Products and Digoxin .... 136
Chinese Botanical Products and Digoxin like
Immunoreactivity .... 137
Limitations of Current Literature .... 137
Specific Issues Regarding Evaluation of Chinese Botanical
Product Drug Interactions .... 138
Contents vij
Conclusion .... 143
References .... 143
7. Drug Interactions of Grapefruit and Other
Citrus—What Have We Learned? 147
S. U. Mertens Talcott, I. Zadezensky, W. V. De Castro,
Veronika Butterweck, and Hartmut Derendorf
Introduction .... 147
Phenolic Compounds in Grapefruit and Citrus
with Potential Drug Interactions .... 149
Possible Mechanisms of Interaction .... 153
Classes of Drugs Interacting with GFJ .... 159
Conclusions .... 176
Future Directives .... 177
References .... 178
8. Quality Assurance and Standardization in Botanical Product Drug
Interaction: Evaluation and Documentation 191
Lucas R. Chadwick and Harry H. S. Fong
Introduction .... 191
Material Quality and Quality Control Issues .... 193
Intrinsic and Extrinsic Factors .... 194
Regulatory Influence .... 196
Quality Assurance and Quality Control .... 197
Clinical Experimental Design and
Data Interpretation .... 200
Conclusion .... 200
References .... 201
9. Pharmacokinetics of Botanical Products 205
Veronika Butterweck and Hartmut Derendorf
Introduction .... 205
Ginkgo Biloba .... 207
St. John s Wort .... 213
Garlic .... 221
Willow Bark .... 224
Horse Chestnut .... 226
Ginseng .... 228
Milk Thistle .... 231
Conclusion .... 235
References .... 235
viii Contents
10. Drug Drug, Drug Dietary Supplement, Drug Citrus
Fruit, and Other Food Interactions—Labeling
Implications 245
Shiew Mei Huang, Lawrence J. Lesko, and Robert Temple
Introduction .... 245
Metabolism of New Molecular Entities and
Interactions with Other Drugs .... 245
Effect of Dietary Supplements on New Molecular
Entities and Interactions .... 252
Effect of Citrus Fruit/Fruit Juice on
New Molecular Entities .... 259
Conclusions .... 271
References .... 272
11. FDA Perspectives on the Use of Postmarketing Reporting Systems
to Evaluate Drug Interactions with CAHP 275
Lori A. Love
Introduction .... 275
Regulatory Classification of Botanical Products .... 276
Safety Concerns Related to Botanicals .... 277
Identification and Evaluation of Potential
Product Interactions .... 278
Adverse Event Reporting at FDA: The
Medwatch Program .... 278
Adverse Events and Risk Management .... 280
References .... 281
12. St. John s Wort Drug Interaction Reports from FDA s
Postmarketing AERS 285
Min Chu Chen
Introduction .... 285
Drug Interactions with St. John s Wort .... 286
Conclusion .... 291
References .... 292
13. Grapefruit Juice Interaction Reports from FDA s
Postmarketing AERS 293
Toni Piazza Hepp
Introduction .... 293
Spontaneous Adverse Event Case Reports .... 293
Case Reports Compared to Labeling .... 297
Contents ix
Plausibility of Drug Grapefruit Juice Interaction .... 300
Conclusion .... 301
References .... 301
14. Botanicals as Drugs: A U.S. Perspective 303
Freddie Ann Hoffman
Introduction .... 303
Regulatory Options .... 305
Historical Perspective .... 305
Complementary and Alternative Medicine .... 308
A New Regulatory Paradigm .... 309
Selecting a Route to Market .... 310
Intended Use .... 311
Advantages of the Drug Route .... 311
Cost .... 313
Whole Is Greater than the Parts .... 314
References .... 315
15. Development of Botanical Products as
Pharmaceutical Agents 319
Shaw T. Chen
Introduction .... 319
The Regulatory Objectives .... 320
The Distinctive Features of Botanicals .... 320
The Botanical Guidance .... 321
Botanical Review Team in Center for Drug Evaluation
and Research .... 322
Review Processes for Botanical Applications .... 323
Botanical Drug Applications in Center for Drug
Evaluation and Research .... 324
Challenges in the Review of Botanical Drug
Applications .... 325
Prospects of Further Development .... 326
Reference .... 326
Index .... 327
|
| adam_txt |
Contents
Preface . Hi
Contributors . xi
1. The Landscape of Botanical Medicine Utilization
and Safety /
Andrew Morris and Michael D. Murray
Introduction . 1
Utilization of Botanical Dietary Supplements
in the United States . 2
Safety of Botanical Products . 8
Conclusions . 19
References . 19
2. Drug Interactions with Botanical Products 25
Y. W. Francis Lam, Shiew Mei Huang, and Stephen D. Hall
Overview of Botanical Drug Interactions . 25
Mechanisms of Botanical Drug Interactions . 26
Altered Pharmacokinetics . 27
Altered Pharmacodynamics . 34
Antagonistic Pharmacodynamic Effect . 37
Evaluating Botanical Drug Interaction . 38
Confounding Issues Related to Study Design . 41
Future . 42
References . 43
V
vi Contents
3. In Vitro Inhibition with Botanical Products 49
Brian C. Foster, John T. Arnason, and Colin J. Briggs
Background . 49
Natural Product Variation . 50
Test Conditions . 62
Product Selection for Clinical Studies . 63
Conclusion . 64
References . 65
4. Drug Interactions with St. John's Wort
and Echinacea 69
J. Christopher Gorski
Introduction . 69
St. John's Wort . 70
Echinacea . 92
References . 95
5. Botanical Products Drug Interactions: Focus on Garlic,
Ginkgo and Ginseng 107
Y. W. Francis Lam and E. Ernst
Introduction . 107
Garlic (Allium Sativum L.) . 108
Ginkgo (Ginkgo Biloba L.) . . . . 112
Asian Ginseng (Panax Ginseng C. A. Meyer) . 115
Comment . 118
References . 119
6. A Review of Chinese Botanical Product Drug
Interactions 123
Y. W. Francis Lam and Ming Ou
Introduction . 123
Chinese Botanical Products and Warfarin . 125
Chinese Botanical Products and Phenprocoumon . 133
Chinese Botanical Products and Aspirin . 134
Chinese Botanical Products and Digoxin . 136
Chinese Botanical Products and Digoxin like
Immunoreactivity . 137
Limitations of Current Literature . 137
Specific Issues Regarding Evaluation of Chinese Botanical
Product Drug Interactions . 138
Contents vij
Conclusion . 143
References . 143
7. Drug Interactions of Grapefruit and Other
Citrus—What Have We Learned? 147
S. U. Mertens Talcott, I. Zadezensky, W. V. De Castro,
Veronika Butterweck, and Hartmut Derendorf
Introduction . 147
Phenolic Compounds in Grapefruit and Citrus
with Potential Drug Interactions . 149
Possible Mechanisms of Interaction . 153
Classes of Drugs Interacting with GFJ . 159
Conclusions . 176
Future Directives . 177
References . 178
8. Quality Assurance and Standardization in Botanical Product Drug
Interaction: Evaluation and Documentation 191
Lucas R. Chadwick and Harry H. S. Fong
Introduction . 191
Material Quality and Quality Control Issues . 193
Intrinsic and Extrinsic Factors . 194
Regulatory Influence . 196
Quality Assurance and Quality Control . 197
Clinical Experimental Design and
Data Interpretation . 200
Conclusion . 200
References . 201
9. Pharmacokinetics of Botanical Products 205
Veronika Butterweck and Hartmut Derendorf
Introduction . 205
Ginkgo Biloba . 207
St. John's Wort . 213
Garlic . 221
Willow Bark . 224
Horse Chestnut . 226
Ginseng . 228
Milk Thistle . 231
Conclusion . 235
References . 235
viii Contents
10. Drug Drug, Drug Dietary Supplement, Drug Citrus
Fruit, and Other Food Interactions—Labeling
Implications 245
Shiew Mei Huang, Lawrence J. Lesko, and Robert Temple
Introduction . 245
Metabolism of New Molecular Entities and
Interactions with Other Drugs . 245
Effect of Dietary Supplements on New Molecular
Entities and Interactions . 252
Effect of Citrus Fruit/Fruit Juice on
New Molecular Entities . 259
Conclusions . 271
References . 272
11. FDA Perspectives on the Use of Postmarketing Reporting Systems
to Evaluate Drug Interactions with CAHP 275
Lori A. Love
Introduction . 275
Regulatory Classification of Botanical Products . 276
Safety Concerns Related to Botanicals . 277
Identification and Evaluation of Potential
Product Interactions . 278
Adverse Event Reporting at FDA: The
Medwatch Program . 278
Adverse Events and Risk Management . 280
References . 281
12. St. John's Wort Drug Interaction Reports from FDA's
Postmarketing AERS 285
Min Chu Chen
Introduction . 285
Drug Interactions with St. John's Wort . 286
Conclusion . 291
References . 292
13. Grapefruit Juice Interaction Reports from FDA's
Postmarketing AERS 293
Toni Piazza Hepp
Introduction . 293
Spontaneous Adverse Event Case Reports . 293
Case Reports Compared to Labeling . 297
Contents ix
Plausibility of Drug Grapefruit Juice Interaction . 300
Conclusion . 301
References . 301
14. Botanicals as Drugs: A U.S. Perspective 303
Freddie Ann Hoffman
Introduction . 303
Regulatory Options . 305
Historical Perspective . 305
Complementary and Alternative Medicine . 308
A New Regulatory Paradigm . 309
Selecting a Route to Market . 310
Intended Use . 311
Advantages of the Drug Route . 311
Cost . 313
Whole Is Greater than the Parts . 314
References . 315
15. Development of Botanical Products as
Pharmaceutical Agents 319
Shaw T. Chen
Introduction . 319
The Regulatory Objectives . 320
The Distinctive Features of Botanicals . 320
The Botanical Guidance . 321
Botanical Review Team in Center for Drug Evaluation
and Research . 322
Review Processes for Botanical Applications . 323
Botanical Drug Applications in Center for Drug
Evaluation and Research . 324
Challenges in the Review of Botanical Drug
Applications . 325
Prospects of Further Development . 326
Reference . 326
Index . 327 |
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| series2 | Drugs and the pharmaceutical sciences |
| spelling | Herbal supplements - drug interactions scientific and regulatory perspectives ed. by Y. W. Francis Lam ... New York [u.a.] Taylor & Francis 2006 XIII, 332 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Drugs and the pharmaceutical sciences 162 Includes bibliographical references and index Consommateurs - Protection - Droit Herbes - Emploi en thérapeutique - Effets secondaires Interactions médicaments-herbes Recht Drug-herb interactions Herbs Therapeutic use Side effects Consumer protection Law and legislation Herb-Drug Interactions Consumer Product Safety Medicine, Herbal legislation & jurisprudence Phytopharmakon (DE-588)4115561-0 gnd rswk-swf Arzneimittelwechselwirkung (DE-588)4003147-0 gnd rswk-swf Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Phytopharmakon (DE-588)4115561-0 s Arzneimittelwechselwirkung (DE-588)4003147-0 s DE-604 Arzneimittelsicherheit (DE-588)4143182-0 s b DE-604 Lam, Y. W. Francis Sonstige oth Drugs and the pharmaceutical sciences 162 (DE-604)BV000002008 162 http://www.loc.gov/catdir/enhancements/fy0660/2006040424-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=014894056&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Herbal supplements - drug interactions scientific and regulatory perspectives Drugs and the pharmaceutical sciences Consommateurs - Protection - Droit Herbes - Emploi en thérapeutique - Effets secondaires Interactions médicaments-herbes Recht Drug-herb interactions Herbs Therapeutic use Side effects Consumer protection Law and legislation Herb-Drug Interactions Consumer Product Safety Medicine, Herbal legislation & jurisprudence Phytopharmakon (DE-588)4115561-0 gnd Arzneimittelwechselwirkung (DE-588)4003147-0 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| subject_GND | (DE-588)4115561-0 (DE-588)4003147-0 (DE-588)4143182-0 (DE-588)4143413-4 |
| title | Herbal supplements - drug interactions scientific and regulatory perspectives |
| title_auth | Herbal supplements - drug interactions scientific and regulatory perspectives |
| title_exact_search | Herbal supplements - drug interactions scientific and regulatory perspectives |
| title_exact_search_txtP | Herbal supplements - drug interactions scientific and regulatory perspectives |
| title_full | Herbal supplements - drug interactions scientific and regulatory perspectives ed. by Y. W. Francis Lam ... |
| title_fullStr | Herbal supplements - drug interactions scientific and regulatory perspectives ed. by Y. W. Francis Lam ... |
| title_full_unstemmed | Herbal supplements - drug interactions scientific and regulatory perspectives ed. by Y. W. Francis Lam ... |
| title_short | Herbal supplements - drug interactions |
| title_sort | herbal supplements drug interactions scientific and regulatory perspectives |
| title_sub | scientific and regulatory perspectives |
| topic | Consommateurs - Protection - Droit Herbes - Emploi en thérapeutique - Effets secondaires Interactions médicaments-herbes Recht Drug-herb interactions Herbs Therapeutic use Side effects Consumer protection Law and legislation Herb-Drug Interactions Consumer Product Safety Medicine, Herbal legislation & jurisprudence Phytopharmakon (DE-588)4115561-0 gnd Arzneimittelwechselwirkung (DE-588)4003147-0 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| topic_facet | Consommateurs - Protection - Droit Herbes - Emploi en thérapeutique - Effets secondaires Interactions médicaments-herbes Recht Drug-herb interactions Herbs Therapeutic use Side effects Consumer protection Law and legislation Herb-Drug Interactions Consumer Product Safety Medicine, Herbal legislation & jurisprudence Phytopharmakon Arzneimittelwechselwirkung Arzneimittelsicherheit Aufsatzsammlung |
| url | http://www.loc.gov/catdir/enhancements/fy0660/2006040424-d.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=014894056&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000002008 |
| work_keys_str_mv | AT lamywfrancis herbalsupplementsdruginteractionsscientificandregulatoryperspectives |