Comparison of 3 Kidney Injury Multiplex Panels in Rats

John-Baptiste, Annette; Vitsky, Allison; Sace, Frederick; Zong, Qing; Ko, Mira; Yafawi, Rolla; Liu, Ling

doi:10.1177/1091581812463348

Cited by 9 publications

(1 citation statement)

References 23 publications

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“…Various groups are further validating the usefulness of these biomarkers in preclinical studies Ozer et al, 2010;Tonomura et al, 2010Tonomura et al, , 2012. There is also a significant ongoing effort to characterize and qualify a panel of safety biomarkers by various groups, and their clinical bringing validation is also underway John-Baptiste et al, 2012;Wadey et al, 2012;Xie et al, 2013). Measurement of a panel of safety biomarkers in parallel would help maximally capture all potential safety signals for a more informative decision to be made in drug research and development as well as for optimal selection of the drug and its dose in clinical practice.…”

Section: Translational Safety Biomarkersmentioning

confidence: 99%

Drug safety testing paradigm, current progress and future challenges: an overview

Ahuja

Sharma

2013

J. Appl. Toxicol.

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Early assessment of the toxicity potential of new molecules in pharmaceutical industry is a multi-dimensional task involving predictive systems and screening approaches to aid in the optimization of lead compounds prior to their entry into development phase. Due to the high attrition rate in the pharma industry in last few years, it has become imperative for the nonclinical toxicologist to focus on novel approaches which could be helpful for early screening of drug candidates. The need is that the toxicologists should change their classical approach to a more investigative approach. This review discusses the developments that allow toxicologists to anticipate safety problems and plan ways to address them earlier than ever before. This includes progress in the field of in vitro models, surrogate models, molecular toxicology, 'omics' technologies, translational safety biomarkers, stem-cell based assays and preclinical imaging. The traditional boundaries between teams focusing on efficacy/ safety and preclinical/ clinical aspects in the pharma industry are disappearing, and translational research-centric organizations with a focused vision of bringing drugs forward safely and rapidly are emerging. Today's toxicologist should collaborate with medicinal chemists, pharmacologists, and clinicians and these value-adding contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

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