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March 15, 2005 (Vol. 25, No. 6)

Addressing Stability of Biological Drugs

Forced Degradation Studies Predict Effects on Bioproducts in Drug Development and Manufacture

  • Forced degradation studies involve exposing a drug substance to harsher conditions than the product would be expected to experience and determining at what point and how it degrades. Identifying strategies to minimize the effects of variable temperature, humidity, and lighting conditions on the structural integrity and biological activity ...

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