Titlebook: Use and Approval of Antihypertensive Agents and Surrogate Endpoints for the Approval of Drugs Affect; Proceedings of the T Joel Morganroth,

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What Should be Required for FDA Approvability of a New Antihypertensive Drug? What is the FDA’s Viewe fairly clear. Antihypertensive drugs are approved on the basis of a demonstrated ability to lower blood pressure to a reasonable degree and a reasonably complete characterization of a drug’s pharmacokinetic and pharmacodynamic properties, with particular emphasis on dose-response and on patient ch

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0166-9842 al and related health care industries, and members of the Food and Drug Administration to discuss important clinical research issues. The Tenth Annual Symposium on New Drugs addressed the problem of whether it was still appropriate to approve antihypertensive agents soley on the endpoint of lowering

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What Should be Required for FDA Approvability of a New Antihypertensive Drug? What is the FDA’s Viewaracteristics that can alter this response. We have not, up to now, sought evidence of diminished end-organ damage or mortality for each new agent, relying instead on the past studies that showed such benefits of lowering blood pressure.

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