Abstract
Clinical development of proposed new therapies requires constant decision making to minimize potential risks. However, for novel therapeutics there is an added enthusiasm to introduce exciting new products into the clinic as quickly as possible. Some enthusiasts have even questioned the need for conducting preclinical (animal) safety studies favoring conservation of resources, reduction in animal usage, the ability to screen early therapeutic concepts more quickly in the ‘ultimate’ species (humans), the realization of patient benefit as early as possible, and/or an earlier opportunity to publish clinical data possibly leading to increased funding to support further research.
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