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In 1976, Comroe and Dripps published the results of their study analyzing the essential information needed to produce the top 10 clinical advances in cardiovascular and pulmonary medicine in the previous 30 years [1]. Some of their findings are relevant to the subject of this book. First, it is striking how long the lag time can be from a scientific discovery to an advance in clinical practice based on that discovery. Second, Comroe and Dripps differentiated basic from nonbasic research according to whether the scientists attempted to determine the mechanisms for the effects observed. Thus, studies in sick people could be basic if they probed mechanisms, whereas studies in cells or of enzymes could be nonbasic if they described events but did not probe for mechanisms. |
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The relevance of these findings to the future health of the public, as the consequences of cost containment in health care impact on the pharmaceutical industry, cannot be overemphasized. The drug discovery process is often perceived as a straight line proceeding from the discovery of a screening technique for a desired pharmacological effect to the synthesis of compounds for screening, to the preclinical development of leading candidates for introduction into humans, to the introduction into humans in Phase I, to the clinical trials in Phases II and III, to the filing of the New Drug Application (or other registration documents), to regulatory approval, to commercial launch and marketing. In reality, the process is more varied and complicated than such a direct progression. As pointed out by Comroe and Dripps, it actually starts much earlier, |
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