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What is CMC Statistics?
Glossary
Resources
Articles by Keith Bower
Biography
Contact
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Home
What is CMC Statistics?
Glossary
Resources
Articles by Keith Bower
Biography
Contact
Home
What is CMC Statistics?
Glossary
Resources
Articles by Keith Bower
Biography
Contact
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 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
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
Many analyses under the umbrella of CMC statistics are described in
this book
by Dr. Richard K. Burdick
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