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Keywords:

  • assay validation
  • biomarker
  • clinical trials
  • Japan
  • standard operating procedure

The pharmaceutical industry has been working on improving drug development since decades. Currently, lack of efficacy and safety concerns are the major causes of attrition during late drug development. Under the current situation, biomarkers including pharmacodynamics (PD) and safety play an important role. Hayashi et al. proved that the use of a biomarker resulted in higher success rates during anticancer drug development

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