Drug research and development (R&D) is a costly high-risk process. Project failure accounts for 75% of cumulative R&D costs. Attempts to strike a balance between pharmacoeconomics and ethics cannot be based on reductions in currently accepted safety standards. Attention should rather be focused on the well-known causes of attrition. For example, problems of absorption, distribution, metabolism and excretion must be resolved during preclinical Phase I, signs of unexpected toxicity must be identified early and wider use must be made of approved surrogate endpoints. The roles of the new omic and analytical technologies have yet to be defined.
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