Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affecting Antiarrhythmic Heart Failure and Hypolipidemia: Proceedings of the Tenth Annual Symposium on New Drugs & Devices, October 31 – November 1, 1989: Developments in Cardiovascular Medicine, cartea 112
Editat de J. Morganroth, E. Neil Mooreen Limba Engleză Hardback – 31 mai 1990
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Specificații
ISBN-13: 9780792307563
ISBN-10: 0792307569
Pagini: 230
Ilustrații: X, 230 p.
Dimensiuni: 155 x 235 x 14 mm
Greutate: 0.52 kg
Ediția:1990
Editura: Springer Us
Colecția Springer
Seria Developments in Cardiovascular Medicine
Locul publicării:New York, NY, United States
ISBN-10: 0792307569
Pagini: 230
Ilustrații: X, 230 p.
Dimensiuni: 155 x 235 x 14 mm
Greutate: 0.52 kg
Ediția:1990
Editura: Springer Us
Colecția Springer
Seria Developments in Cardiovascular Medicine
Locul publicării:New York, NY, United States
Public țintă
ResearchCuprins
I. Approaches and Methods to Studying Antihypertensive Drugs.- 1. New concepts in antihypertensive drug therapy.- 2. Is ambulatory blood pressure monitoring required to define the hypertensive patient and to detect efficacy?.- 3. What vascular effects should be measured in antihypertensive drug research?.- 4. Is it necessary to demonstrate changes in left ventricular hypertrophy in the evaluation of antihypertensive drugs?.- 5. Clinical trials of antihypertensive agents.- 6. How does one define dose-duration of an antihypertensive drug? What is the role of non-Mem and the Peak/Through measurement.- II. What Should be Required for FDA Approvability of a New Antihypertensive Drug?.- 7. What have we learned from prior clinical trials of antihypertensive drug therapy?.- 8. Are specific studies in elderly patients required for FDA approvability of a new antihypertensive drug?.- 9. Do we need any more antihypertensive drugs: The validity of a change in blood pressure as the only endpoint for approvability?.- 10. The cost and time to develop a new antihypertensive drug depending upon the endpoint.- III. Surrogate Endpoints to Define Risk VS. Benefits.- 11. What should be required for FDA approvability of a new antihypertensive drug? What is the FDA’s viewpoint?.- 12. Are there valid surrogate endpoints for mortality that can be used to evaluate the effects of antiarrhythmic drug therapy?.- 13. How to demonstrate the efficacy of a new drug for the treatment of chronic heart failure.- 14. Testing the relationship between cholesterol lowering and cardiovascular disease — past, present, and prospects.- Participant List.