What is CMC Statistics?

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 assure 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

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
Many analyses under the umbrella of CMC statistics are described in this book by Dr. Richard K. Burdick