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Developing and Validating Assays for Small-Molecule Biomarkers.

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اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • المؤلفون: Challener, Cynthia A.
  • المصدر:
    Pharmaceutical Technology Europe. Feb2015, Vol. 27 Issue 2, p20-24. 4p.
  • معلومة اضافية
    • الموضوع:
      PHARMACEUTICAL industry; UNITED States. Food & Drug Administration; BIOMARKERS; BIOINDICATORS; DRUG standards
    • الموضوع:
      EUROPE
    • نبذة مختصرة :
      The article examines issues faced by the pharmaceutical industry in Europe in developing and validating assays for small-molecule biomarkers in comparison to active pharmaceutical ingredients (APIs). Topics include the difficulty in the use of biomarkers as they are endogenous compounds in biological fluids, in some cases the samples need to be purified before a biomarker assay can be completed unlike APIs, and the U.S. Food and Drug Administration's guidance regarding validation of assays.