Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop

  title={Translational Biomarkers: from Preclinical to Clinical a Report of 2009 AAPS/ACCP Biomarker Workshop},
  author={Jane P. F. Bai and Robert Bell and Shaavhr{\'e}e Buckman and Gilbert J. Burckart and H G Eichler and Kenneth C. Fang and Federico M. Goodsaid and William J. Jusko and Lawrence L. Lesko and Bernd Meibohm and Scott Patterson and Oscar Puig and Jeffrey B. Smerage and Barbara Joy Snider and John J. Wagner and Jingsong Wang and Marc K. Walton and Russell Weiner},
  journal={The AAPS Journal},
There have been some successes in qualifying biomarkers and applying them to drug development and clinical treatment of various diseases. A recent success is illustrated by a collaborative effort among the US Food and Drug Administration, the European Medicines Agency, and the pharmaceutical industry to provide a set of seven preclinical kidney toxicity biomarkers for drug development. Other successes include, but are not limited to, clinical biomarkers for cancer treatment and clinical… CONTINUE READING
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