Translational Medicine: Reducing Uncertainty in Drug DevelopmentFew products can compare to pharmaceuticals in terms of their development costs, testing complexities, regulatory requirements, and potential safety issues—although we could argue that passenger aircraft are in the same league. Consider, then, what a shock it would be to an aircraft designer if during the flight certification, the new aircraft couldn't get off the ground. In contrast, many pharmaceutical manufacturers get to a similar stage in their own products' development only to find that they won't "fly." We understand the physical laws that govern aerodynamics better than we understand the biological laws of drug action and disease response. |
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The Eyes Have ItThe early clinical phases of drug development present a unique opportunity to characterize and more fully understand the pharmacodynamic effects of potential pharmaceutical products. This article explores how simple measurements involving the eyes can be used to investigate the side-effect profile of compounds, better understand the mechanisms involved in the pathophysiology of CNS disease states, and demonstrate target engagement of drugs. |
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ICON ProfileRoger Toothaker, Ph.D. - Vice President, Pharmacokinetics, Pharmacodynamics, Modeling and Simulation, ICON Development Solutions |
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Did you know?Fast Facts. |
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