A new Spotlight on CDER Science has been posted. The topic is: "CDER Scientists Use Modern Measurement Tools for Quality Assurance and Comparability of Complex Drugs."
This Spotlight is by David A. Keire, Ph.D., Director, Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research.
When scientists in the Office of Testing and Research (OTR) in CDER’s Office of Pharmaceutical Quality (OPQ) need to demonstrate the quality and performance of a drug product, they use a variety of novel analytical techniques. These techniques help to assess specific information about a drug or drug product, such as its chemical structure, purity, and quantity of active ingredient. For commonly used drugs like aspirin, “classical” analytical methods to measure these properties work well to spot problems in the drug that could impair its safety or effectiveness.
Increasingly, the drugs that are approved for use in people are becoming more complex. Some drugs are complex because they are mixtures of closely related molecules that together result in drug action. Some drugs are considered complex because they are designed to function in the patient over long periods of time or to be delivered to certain areas within the body. Some complex drugs are manufactured and purified from living cells, and at the molecular level, such drugs are typically larger than traditional drugs. Because of this complexity, OTR scientists often need to use advanced analytical methods to provide assurance of drug safety and effectiveness.
For more information, please visit: Complex Drugs.
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