The Symposium on New Drugs provides a forum for academic investigators, research and development personnel from the pharmaceutical industry and members of the Food and Drug Administration to discuss important clinical research issues. The Ninth Annual symposium on New Drugs addressed the problem of determining the risk versus benefit for use of three important classes of cardiovascular agents: thrombolytic, antiarrhythmic, and hypolipidemic agents. The use of thrombolytic agents has become one of the major advances in clinical intensive cardiologic care in the 1980s. While the lysis of...

About 2. 5 million individuals have congestive heart fai lure in the United States with over 400,000 new cases expected annually. Congestive heart failure also is one of the commonest causes for hospital admissions accounting for over 5 million hospital days per year. Despite the early recognition of this condition and active medical research into both mechanisms and therapy, prognosis continues to remain dismal wi th less than a 50% expected five year survival. In the last decade we have seen many new medical and therapeutic options for patients with congestive heart failure which extend...

It is generally easy to define the efficacy of a new the- peutic agent. However, what is even more difficult and more challenging yet more important is to define its safety when administered to millions of patients with multi-faceted d- eases, co-morbidities, sensitivities and concomitant medi- tions. The commonest cause of new drug discontinuations, cause for disapproval from marketing and removal from the market after approval is a drug's effect on cardiac repolari- tion which is essentially identified by increasing the duration of the QTc interval duration on the standard 12-lead elect-...

In summary, there are many animal models that are useful in selecting new antiarrhythmic drugs. The selection of which model is most idea depends upon precisely what question is being asked. The large number of experimental models used to evaluate antiarrhythmic compounds points out the inability of anyone model to define the probability of antiarrhythmic efficacy in man. It has therefore become standard practice to utilize a batter of animal models for the evaluation of new antiarrhythmic agents. Each model has its own advantages and disadvantages and it is necessary to understand each model...

In Harch of 1980, we organized the first symposium on how to evaluate new antiarrhythmic agents in which the participants included members of the Cardio-Renal Division of the Food and Drug Administration, academic investigators from the United States and Abroad and directors and imple mentors of pharmacological research representing the pharmaceutical industry. By bringing together all three elements, it was hoped that better communication and under standing would ensue to more rapidly bring new cardiac agents to the American public. This goal was important since a rather limited number of...

The Symposium on New Drugs provides for an annual forum for academic investigators, research and development personnel from the pharmaceutical 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 cuff blood pressure. The initial discussions at this symposium related to the approaches and methods to studying antihypertensive agents. Dr. William Frishman...

It is generally easy to define the efficacy of a new the- peutic agent. However, what is even more difficult and more challenging yet more important is to define its safety when administered to millions of patients with multi-faceted d- eases, co-morbidities, sensitivities and concomitant medi- tions. The commonest cause of new drug discontinuations, cause for disapproval from marketing and removal from the market after approval is a drug s effect on cardiac repolari- tion which is essentially identified by increasing the duration of the QTc interval duration on the standard 12-lead elect-...