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    • Home
    • What is CMC Statistics?
    • Glossary
    • Useful Rules
    • Multimedia
    • Publications
    • Biography
  • Home
  • What is CMC Statistics?
  • Glossary
  • Useful Rules
  • Multimedia
  • Publications
  • Biography

What is CMC Statistics?

Chemistry, Manufacturing, and Controls (CMC) statistical techniques are used:

  • To assure that the drug sold to the public will have quality attributes similar to those of the drug demonstrated to be safe and effective
  • To ensure that the quality of the drug meets appropriate standards and is consistent
  • To assure that the drug you are using is the drug described on the label

Examples of analyses performed by a CMC Statistician

  • Assist in setting release and stability acceptance criteria for drug product and drug substance
  • Shelf life determination and expiry extension for drug product
  • Qualification of reference standards
  • Calculating control chart limits to monitor manufacturing results
  • Consult with subject matter experts to design and analyze the results of an experiment
  • Biosimilarity acceptance criteria to assist in the approval of a biosimilar

What is the difference between a CMC Statistician and a Biostatistician?

  • Biostatisticians assess the results from patients who experience the drug product during a clinical trial
  • CMC Statisticians do not address the results from clinical trials

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