Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs
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| Sprache: | English |
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New York, NY, Oxford
Oxford University Press
1995
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| 245 | 1 | 0 | |a Ethical issues in drug testing, approval, and pricing |b the clot-dissolving drugs |c Baruch A. Brody, Ph.D. |
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| adam_text | IMAGE 1
ETHICAL ISSUES
IN DRUG TESTING, APPROVAL, AND PRICING THE CLOT-DISSOLVING DRUGS
BARUCH A. BRODY, PH.D.
NEW YORK OXFORD OXFORD UNIVERSITY PRESS 1995
IMAGE 2
CONTENTS
INTRODUCTION, 3
1. THE DEVELOPMENT OF THROMBOLYTIC THERAPY, 5
THE MEDICAL BACKGROUND, 5
THE YEARS OF PROMISE, 14
1982: A YEAR OF CONSOLIDATION AND FURTHER INITIATIVES, 20
BIOTECHNOLOGY, GENENTECH, AND TPA, 27
THE GREAT CLINICAL TRIALS, 29
1987: THE YEAR OF FDA APPROVAL, 45
MONEY ISSUES, 54
THE END OF THE STORY, 73
FINAL CONSIDERATIONS, 83
APPENDIX A. TIMETABLE OF INITIAL CLINICAL TRIALS OF THROMBOLYTIC AGENTS,
85
APPENDIX B. ESTIMATES OF ADDITIONAL SHORT-TERM DEATHS IN PLACEBO CONTROL
GROUPS, 87
APPENDIX C. BACKUP CALCULATIONS FOR ESTIMATES OF ADDITIONAL DEATHS IN
PLACEBO CONTROL GROUPS, 88
NOTES, 89
2. TROUBLING ETHICAL ISSUES IN THE CONDUCT OF CLINICAL TRIALS, 99
A SELECTED SURVEY OF STATEMENTS OF PRINCIPLES AND REGULATIONS, 99
THE USE OF PLACEBOS IN CLINICAL TRIALS, 112
CONSENT IN THE EMERGENCY ROOM, 131
CONFLICTS OF INTERESTS AND THE VALIDITY OF CLINICAL TRIALS, 144
CONCLUSIONS, 152
NOTES, 153
IMAGE 3
X CONTENTS
3. TROUBLING ETHICAL ISSUES IN THE APPROVAL OF NEW DRUGS, 158
THE DEVELOPMENT OF THE FDA REGULATORY SCHEME IN THE UNITED STATES, 159
ALTERNATIVE REGULATORY SCHEMES IN OTHER COUNTRIES, 181
THE ETHICAL FOUNDATIONS OF AN APPROPRIATE DRUG REGULATION SCHEME, 192
NOTES, 204
4. TROUBLING ETHICAL ISSUES IN DRUG ADOPTION, 210
PRICES, CLINICAL CHOICES, AND REIMBURSEMENT POLICIES, 210
THE PRICES OF DRUGS, 229
NOTES, 250
CONCLUSIONS, 254
INDEX, 257
|
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| illustrated | Not Illustrated |
| indexdate | 2024-12-24T00:48:44Z |
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| isbn | 019508831X |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-022070399 |
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| physical | X, 268 Seiten |
| publishDate | 1995 |
| publishDateSearch | 1995 |
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| publisher | Oxford University Press |
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| spellingShingle | Brody, Baruch A. Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs |
| title | Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs |
| title_auth | Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs |
| title_exact_search | Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs |
| title_full | Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs Baruch A. Brody, Ph.D. |
| title_fullStr | Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs Baruch A. Brody, Ph.D. |
| title_full_unstemmed | Ethical issues in drug testing, approval, and pricing the clot-dissolving drugs Baruch A. Brody, Ph.D. |
| title_short | Ethical issues in drug testing, approval, and pricing |
| title_sort | ethical issues in drug testing approval and pricing the clot dissolving drugs |
| title_sub | the clot-dissolving drugs |
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