News & Events

• May 10, 2010
  

  Urinary Clusterin, Cystatin C, [beta]2-Microglobulin and Total Protein as Markers to Detect Drug-Induced Kidney Injury

  Dieterle F, Perentes E, Cordier A, Roth DR, Verdes P, Grenet O, Pantano S, Moulin P, Wahl D, Mahl A, End P, Staedtler F, Legay F, Carl K, Laurie D, Chibout SD, Vonderscher J, Maurer G. Urinary Clusterin, Cystatin C, [beta]2-Microglobulin and Total Protein as Markers to Detect Drug-Induced Kidney Injury. Nature Biotechnology. 2010 May;28(5):463–9.

   

• May 10, 2010
  

  Renal Biomarker Qualification Submission: A Dialog Between the FDA-EMEA and Predictive Safety Testing Consortium

  Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W. Renal Biomarker Qualification Submission: A Dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nature Biotechnology. 2010 May;28(5):455–62.

• May 1, 2010
  

  Research at the Interface of Industry, Academia and Regulatory Science

  Mattes WB, Walker EG, Abadie E, Sistare FD, Vonderscher J, Woodcock J, Woosley RL. Research at the Interface of Industry, Academia and Regulatory Science. Nature Biotechnology. 2010 May;28(5):432–3.

   

• May 1, 2010
  

  Evolution of Biomarker Qualification at the Health Authorities

  Goodsaid F, Papaluca M. Evolution of Biomarker Qualification at the Health Authorities. Nature Biotechechnology. 2010 May;28(5):441–3.

   

• May 1, 2010
  

  Next-Generation Biomarkers for Detecting Kidney Toxicity

  Bonventre JV, Vaidya VS, Schmouder R, Feig P, Dieterle F. Next-Generation Biomarkers for Detecting Kidney Toxicity. Nature Biotechnology. 2010 May;28(5):436–40.