Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents :
General Material Designation
[Book]
Other Title Information
Proceedings of the Ninth Annual Symposium on New Drugs & Devices, October 27 & 28, 1988
First Statement of Responsibility
edited by Joel Morganroth, E. Neil Moore.
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Boston, MA
Name of Publisher, Distributor, etc.
Springer US
Date of Publication, Distribution, etc.
1989
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
(316 pages).
SERIES
Series Title
Developments in cardiovascular medicine, 100.
CONTENTS NOTE
Text of Note
I. Thrombolytic Agents: Clinical Trials ISSUES --;1. Measurement of infarct size: effect of reperfusion with arterial blood --;2. Pitfalls in the design and evaluation of clinical trials of intravenously administered cardiovascular drugs --;3. The relative benefit and risks of intravenous streptokinase and tissue plasminogen activator in acute myocardial infarction --;4. New agents and new insights for thrombolytic therapy in acute myocardial infarction: focus on anistreplase, urokinase, and prourokinase --;5. Myocardial reperfusion: Role of adjunctive agents to improve reperfusion and prevent reperfusion injury --;Panel Discussion --;II. Thrombolytic Agents: Adjunctive Issues --;6. Interactions between thrombolysis and sudden cardiac death --;7. What are the overall strategies for post-thrombolytic care that include use of angioplasty? --;8. Thrombolytic agents: biologic properties and issues regarding products derived by recombinant DNA technology --;Panel Discussion --;III. Risk vs. Benefit for Antiarrhythmic Drugs --;9. What do new anti-arrhythmic agents have to show to establish a favorable risk versus benefit ratio? --;10. What do new cardiovascular agents (e.g. antiarrhythmic drugs) have to show to establish a favorable risk versus benefit ratio to obtain approvability? --;clinical viewpoint --;11. Is it practical to develop a class III antiarrhythmic agent? --;Panel Discussion --;IV. Hypolipidemic Agents: Clinical & Regulatory Issues --;12. What are the recommendations to the medical community to institute hypolipidemic therapy? --;13. What are the comparative risks versus benefits for bile acid sequestrants, HMG CO-A reductase inhibitors, nicotinic acid, probucol, and fibric acid derivatives? --;14. What levels of cholesterol should be studied and what should be the study designs? --;15. Should a change in the atherosclerotic process be required for approval of new hypolipidemic agents? --;16. How and when should long-term safety data be obtained for hypolipidemic agents? --;17. What is required to gain approval of lipid altering drugs? --;Panel Discussion --;Participant List.
SUMMARY OR ABSTRACT
Text of Note
Proceedings of the Ninth Annual Symposium on New Drugs & Devices, October 27 and 28, 1988
PARALLEL TITLE PROPER
Parallel Title
Proceedings of the Ninth Annual Symposium on New Drugs & Devices, October 27 and 28, 1988