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Novel targets for the prevention of osteoporosis – lessons learned from studies of metabolic bone disorders.

January 1, 2015

Expert Opin Ther Targets

Abstract INTRODUCTION Osteoporosis is a major health care problem, and whereas efficacious treatments for vertebral fracture reduction are available for osteoporosis patients, these therapies are still limited with respect to capacity for restoration of bone loss, as well as efficacy on non-vertebral fractures, such as hip fractures, which are the source of morbidity and mortality. […]

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Serological biochemical markers of surrogate efficacy and safety as a novel approach to drug repositioning.

November 1, 2011

Drug Discov Today

Abstract How do pharmaceutical companies find new uses for old or failed drugs? Is there a way to ‘manage serendipity’ at the very first stage of identifying compounds that could be developed into new drugs? Several approaches are now being pursued by various companies that are dedicated to drug repositioning cross a spectrum of technologies […]

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Biochemical markers and the FDA Critical Path: how biomarkers may contribute to the understanding of pathophysiology and provide unique and necessary tools for drug development.

May 1, 2009

Biomarkers

Abstract The aim of this review is to discuss the potential usefulness of a novel class of biochemical markers, neoepitopes, in the context of the US Food and Drug Administration (FDA) Critical Path Initiative, which emphasizes biomarkers of safety and efficacy as areas of pivotal interest. Examples of protein degradation fragments–neoepitopes–that have proven useful for […]

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Application of biomarkers in the clinical development of new drugs for chondroprotection in destructive joint diseases: a review.

December 1, 2006

Biomarkers

Abstract Emerging evidence supports the concept that biochemical markers are clinically useful non-invasive diagnostic tools for the monitoring of changes in cartilage turnover in patients with destructive joint diseases such as osteoarthritis (OA) and rheumatoid arthritis (RA). Epidemiological studies demonstrated that measurements of different degradation products of proteins in the extracellular matrix of hyaline cartilage […]

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