Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement

@article{Lee2005FitforPurposeMD,
  title={Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement},
  author={Jean Wenqing. Lee and Viswanath Devanarayan and Yu Chen Barrett and Russell Weiner and J. Allinson and Scott Fountain and Stephen W. Keller and Ira Weinryb and M Green and Larry Duan and James Allen Rogers and R. Millham and Peter James O'Brien and Jeff M. Sailstad and Masood Khan and Chad Ray and John Arthur Wagner},
  journal={Pharmaceutical Research},
  year={2005},
  volume={23},
  pages={312-328}
}
Despite major advances in modern drug discovery and development, the number of new drug approvals has not kept pace with the increased cost of their development. Increasingly, innovative uses of biomarkers are employed in an attempt to speed new drugs to market. Still, widespread adoption of biomarkers is impeded by limited experience interpreting biomarker data and an unclear regulatory climate. Key differences preclude the direct application of existing validation paradigms for drug analysis… CONTINUE READING
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