Drug discovery today
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Drug discovery today · Aug 2012
ReviewTranslation of drug effects from experimental models of neuropathic pain and analgesia to humans.
Neuropathic pain research remains a challenging undertaking owing to: (i) the lack of understanding about the underlying disease processes; and (ii) poor predictive validity of the current models of evoked pain used for the screening of novel compounds. Common consensus is that experimental models replicate symptoms (i.e. have face validity but no construct validity). ⋯ In this paper we provide an overview of the pre-clinical models that can be used in conjunction with a model-based approach to facilitate the prediction of drug effects in humans. Our review strongly suggests that evidence of the concentration-effect relationship is necessary for translational purposes.
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Drug discovery today · Aug 2012
Characteristics of rare disease marketing applications associated with FDA product approvals 2006-2010.
New drug and biologic product marketing applications submitted to FDA's Center for Drug Evaluation and Research (CDER) between 2006 and 2010 were analyzed to identify rare disease application characteristics associated with higher approval rates. The results show that approval rates were similar for rare and common disease applications. Larger company size, prior regulatory experience and priority review designation were associated with higher approval rates. The study findings show that rare disease product development is feasible, and increased interactions between product developers and FDA in early investigational phases can facilitate product development.