A guidance for renal biomarker lead optimization and use in translational pharmacodynamics.

@article{Ozer2010AGF,
  title={A guidance for renal biomarker lead optimization and use in translational pharmacodynamics.},
  author={Josef S. Ozer},
  journal={Drug discovery today},
  year={2010},
  volume={15 3-4},
  pages={
          142-7
        }
}
Guidance for the use of biomarkers in pharmaceutical development and clinical trial optimization will reduce developmental cycle time. A 'fit-for-purpose' guidance for biomarker use is considered herein when the same biomarker is applied in very different contexts in drug development and after regulatory approval. Recent approved use of renal safety biomarkers in Good Laboratory Practice studies lacks sufficient guidance for the use of these markers across the drug development pipeline. In lead… CONTINUE READING
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