Drug discovery today
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Drug discovery today · Jan 2011
ReviewCharacteristics of orphan drug applications that fail to achieve marketing approval in the USA.
The US Orphan Drug Act has fostered the development of drugs for patients with rare diseases by granting 'orphan designations', although several orphan drugs for which a marketing application has been submitted to the FDA have failed to obtain approval. This study identified the clinical trial design, the level of experience of the sponsor and the level of interaction with the FDA to be associated with non-approval. Sponsors, therefore, should engage in dialogue with the FDA and thoughtfully design pivotal clinical trials in accordance with FDA guidance documents.
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Drug discovery today · Jan 2011
ReviewCreativity, innovation and lean sigma: a controversial combination?
The application of lean sigma is gaining momentum in drug discovery and development but it remains controversial because of perceptions that process improvement will suppress much-needed creativity and innovation. We review the conditions required to support creativity and innovation and the principles and benefits of lean sigma in a drug discovery environment. We conclude that it is desirable to create a unified climate that encourages and enables both innovation and continuous improvement and that this is possible if three key tensions are handled carefully and with due respect to the needs of research. These three potential traps occur in the interpretation of standardization, the role of variation and the choice of how to use liberated capacity.
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Drug discovery today · Oct 2010
ReviewArginine vasopressin receptor antagonists (vaptans): pharmacological tools and potential therapeutic agents.
Arginine vasopressin (AVP) attracted attention as a potentially important neurohormonal mediator of the heart failure (HF) syndrome and hyponatremic states in humans because AVP influences renal handling of free water, vasoconstriction and myocyte biology through activation of V₂ and V₁(a) receptors. Current research is exploring V₂- and dual V₁(a)/V₂ receptor antagonism for the treatment of hyponatremia, as well as for the congestion and edema associated with chronic HF, because vasopressin receptor antagonists might offer benefits in comparison with conventional loop diuretics. The purpose of this review is to update the current status of experimental and clinical studies with available vasopressin receptor antagonists (conivaptan and tolvaptan) and their potential role in the treatment of HF and hyponatremia of multiple causes.
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Drug discovery today · Oct 2010
ReviewCancer nanotechnology: application of nanotechnology in cancer therapy.
The application of nanotechnology for cancer therapy has received considerable attention in recent years. Cancer nanotechnology (an interdisciplinary area of research in science, engineering and medicine) is an upcoming field with extensive applications. ⋯ Target-specific drug therapy and methods for early diagnosis of pathologies are the priority research areas in which nanotechnology would play a vital part. This review focuses on the approaches of cancer nanotechnology in the advancement of cancer therapy.
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Drug discovery today · Aug 2010
ReviewCurrent endovascular treatment of acute stroke and future aspects.
Acute ischemic stroke remains a condition of high morbidity and mortality. Until now, the only established therapy has been intravenous (IV) tissue-type plasminogen activator (tPA). ⋯ Beyond that window of opportunity, and additionally to IV treatment, interventional stroke therapy has assumed an important role for the treatment of acute ischemic stroke. Currently, new promising pharmacological and mechanical treatment options are being established as routine procedures to achieve a further improved outcome for stroke patients.