Download Cardiovascular Drug Development: Protocol Design and by John Somberg PDF

By John Somberg

Those multidisciplinary shows supply details necessary to devising potent drug protocols in cardiovascular drug improvement, facilitating the approval method. courses researchers and builders during the executive drug approval approach, facilitating improvement, minimizing expenses, and harmonizing foreign criteria hired within the production of important new cardiovascular remedies! Cardiovascular Drug improvement ·explores the fragile stability of efficacy and defense that cardiovascular treatment needs to in attaining to achieve regulatory approval ·discusses the hunt for surrogates and the necessity in a few parts for common background endpoints ·reviews optimal concepts for protocol layout within the improvement of substances to regard high blood pressure, cardiac arrhythmias, center failure, coronary artery illness, and hypercholesterolemia and different lipid problems ·compares and contrasts the various criteria of proof for drug approval within the usa, Europe, and Asia ·and extra! Cardiovascular Drug improvement will end up to be a important asset for cardiologists, pharmacologists and pharmacists, regulatory affairs experts, and administrators of analysis and improvement for pharmaceutical businesses.

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Cardiovascular Drug Development: Protocol Design and Methodology (Fundamental and Clinical Cardiology , Vol 35)

Those multidisciplinary displays supply details necessary to devising potent drug protocols in cardiovascular drug improvement, facilitating the approval procedure. publications researchers and builders throughout the executive drug approval procedure, facilitating improvement, minimizing charges, and harmonizing foreign criteria hired within the production of significant new cardiovascular remedies!

Additional info for Cardiovascular Drug Development: Protocol Design and Methodology (Fundamental and Clinical Cardiology , Vol 35)

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What is often a surprise is that development is applied in a general manner without a clear understanding of the market needs or careful preclinical testing of the drug’s effectiveness, especially as compared to other available agents. The remaining portions of this chapter are directed toward cardiovascular drug development; however, the discussion could be generalized to other areas of drug development as well. When one is considering developing an antiarrhythmic, there is a need to go beyond the antiarrhythmic label.

Then there are other companies that neither discover nor develop drugs but place their energy in the marketing of developed pharmaceuticals. One may argue that the niche enterprises are doomed to failure. But a number of factors combine to make this approach viable. The total overhead of the very large companies limits development to compounds expected to have sales of at least $100 million. At times, a drug will have a smaller market and a large company will develop the product for public relations because of interest in the field to bolster sales of existing products in their product line or out of sheer miscalculation of market potential.

We can do better than this and more and more studies, due to FDA insistence more often than not, are rather elegantly determining the effective dose range. It is also important to state that an effective dose for one individual may not be an effective dose for another individual. Thus, differences may not just vary on an individual basis, but may vary within special populations. In fact, it is rather important early on to try to look at a more homogeneous population and exclude the special populations to come up with a reasonable dose range.

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