What you need to know about regulatory compliance, good manufacturing practices (GMPs), and validation, including evolving regulatory policy and developments in biosimilars.
February 2, 2010
If you are looking for additional information (or terms not included in our glossary), here are some places to begin your search.
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February 2, 2010
A Guide to the Biopharmaceutical Lexicon, 2010 edition
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February 2, 2010
UPLC, QTof, HDMS, and more: A practical guide to the hottest techniques driving the future of biopharmaceutical science.
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January 1, 2010
By:Laura Bush
QbD has always embraced the notion that companies could make certain process changes without regulatory oversight.
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January 1, 2010
By:Jill Wechsler
Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.
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December 18, 2009
By:Jon S. Kauffman, PhD
Best methods to monitor product-related impurities throughout the production process.
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December 1, 2009
By:Jill Wechsler
Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.
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December 1, 2009
By:Laura Bush
Do we really have to choose between saving money and saving time?
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