Safety Assessment in Drug Discovery

Sasseville, Vito G.; Foster, William; Car, Bruce D.

doi:10.1002/9780470574898.ch9

Cited by 2 publications

(1 citation statement)

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“…27 Moreover, although both genome-wide and differential expression of select gene sets has been applied at all stages of drug discovery and development from early in vitro assays through nonclinical pharmacology and toxicology studies and clinical trials, the lack of qualified markers and validated methods, as well as accessible tissues (eg, usually limited to peripheral blood cells) in clinical trials, severely limits its use in studies to support regulatory filings. 76 However, transcriptomic data can still make useful contributions toward characterization of the safety of a compound, particularly when used in combination with other ''omics'' technologies and with traditional toxicology end points. The InnoMed PredTox project is a European collaborative effort of pharmaceutical companies, service providers, and universities investigating mechanisms of toxicity and identifying safety biomarker candidates by evaluating a combination of results from transcriptomics, metabolomics, and proteomics in relation to routine clinical chemistry and histopathology.…”

Section: Transcriptomics Metabonomics/metabolomics and Proteomicsmentioning

confidence: 99%

Safety Biomarkers in Preclinical Development

Sasseville¹,

Mansfield²,

Brees

2013

Vet Pathol

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The identification, application, and qualification of safety biomarkers are becoming increasingly critical to successful drug discovery and development as companies are striving to develop drugs for difficult targets and for novel disease indications in a risk-adverse environment. Translational safety biomarkers that are minimally invasive and monitor drug-induced toxicity during human clinical trials are urgently needed to assess whether toxicities observed in preclinical toxicology studies are relevant to humans at therapeutic doses. The interpretation of data during the biomarker qualification phase should include careful consideration of the analytic method used, the biology, pharmacokinetic and pharmacodynamic properties of the biomarker, and the pathophysiology of the process studied. The purpose of this review is to summarize commonly employed technologies in the development of fluidand tissue-based safety biomarkers in drug discovery and development and to highlight areas of ongoing novel assay development.

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Section: Transcriptomics Metabonomics/metabolomics and Proteomicsmentioning

confidence: 99%