title: The current status of biomarkers for predicting toxicity.
abstract: BACKGROUND
  There are significant rates of attrition in drug development. A number of compounds fail to progress past preclinical development due to limited tools that accurately monitor toxicity in preclinical studies and in the clinic. Research has focused on improving tools for the detection of organ-specific toxicity through the identification and characterization of biomarkers of toxicity.
  
  
  METHODS
  This article reviews what we know about emerging biomarkers in toxicology, with a focus on the 2012 Northeast Society of Toxicology meeting titled 'Translational Biomarkers in Toxicology.' The areas covered in this meeting are summarized and include biomarkers of testicular injury and dysfunction, emerging biomarkers of kidney injury and translation of emerging biomarkers from preclinical species to human populations. The authors also provide a discussion about the biomarker qualification process and possible improvements to this process.
  
  
  CONCLUSIONS
  There is currently a gap between the scientific work in the development and qualification of novel biomarkers for nonclinical drug safety assessment and how these biomarkers are actually used in drug safety assessment. A clear and efficient path to regulatory acceptance is needed so that breakthroughs in the biomarker toolkit for nonclinical drug safety assessment can be utilized to aid in the drug development process.
authors: Drug Safety Research and Development, Pfizer, Inc. , Eastern Point Road, MS 8274 1260, Groton, CT 06340 , USA.
authors: Sarah
authors: S
authors: Campion
authors: Jiri
authors: J
authors: Aubrecht
authors: Kim
authors: K
authors: Boekelheide
authors: David W
authors: DW
authors: Brewster
authors: Vishal S
authors: VS
authors: Vaidya
authors: Linnea
authors: L
authors: Anderson
authors: Deborah
authors: D
authors: Burt
authors: Edward
authors: E
authors: Dere
authors: Kathleen
authors: K
authors: Hwang
authors: Sara
authors: S
authors: Pacheco
authors: Janani
authors: J
authors: Saikumar
authors: Shelli
authors: S
authors: Schomaker
authors: Mark
authors: M
authors: Sigman
authors: Federico
authors: F
authors: Goodsaid
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced / Q000175:diagnosis; D000818:Animals; D015415:Biomarkers / Q000097:blood*; D004195:Disease Models, Animal; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D008297:Male; D013733:Testicular Diseases / Q000139:chemically induced / Q000175:diagnosis; D013737:Testis / Q000187:drug effects / Q000473:pathology
chemical_list: D015415:Biomarkers
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