Drug Development
Method to estimate safe starting dose in phase I trials presented
Published in Medical Letter on the CDC and FDA, March 6th, 2005
According to a study from the United States, "Estimating the maximum recommended starting dose (MRSD) of a pharmaceutical for phase I human clinical trials and the no observed effect level (NOEL) for non-pharmaceuticals is currently based exclusively on an extrapolation of the results of animal toxicity studies. This process is inexact and requires the results of toxicity studies in multiple species (rat, dog, and monkey) to identify the no observed adverse effect level (NOAEL)...
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